Public FDA Data → AI Entity Resolver → Connected Facility Graph
Every FDA-Regulated Factory in One Connected Graph.
Enterprise pharma pays $50,000/yr to connect scattered FDA inspection databases. We built the open map of who makes what, where, and how they performed in their last FDA inspection — linking Form 483s, Warning Letters, Recalls, DECRS Registrations, and Border Refusals to a transparent FDA Record Index (0–100).
Product 1 · Brand Acquisition
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1. Clean-Record Co-Packer Finder
Match your gummy, supplement, skincare, food, or chemical SKU with manufacturers whose real FDA inspection record is verified next to their quote.
Product 2 · AI Workforce
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2. AI Mock FDA Inspection
Upload your SOPs, MMRs, batch records, and cleaning logs. Our AI grades them against 1,620+ 21 CFR citation patterns and shows what an inspector would write up.
Product 3 · Recurring SaaS
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3. Supplier Watchlist & 483 Store
Upload your vendor list and get an instant email or Slack alert the moment a supplier gets a Form 483, recall, warning letter, or border refusal.
2,333
ORA Reading Room 483s
1,620
21 CFR Citation Templates
337,116
Device Registrations
138,244
Drug / OTC NDC Listings
88,112
FDA Enforcement Recalls
259 / 362
Seeded Indexable / Total Nodes
Canonical FDA Facility Graph (224 matching facilities)
Showing cross-database resolved establishments with FEI/DUNS linkage, FDA Record Index scores, and peer percentile rankings.
QuVa Pharma Inc
BBB
78/100 · Moderate (VAI)
FEI: 3012053582 · TX, United States
Pharmaceuticals & Sterile/OTC Drugs
VERIFIED CO-PACKER
1
483s
0
Warn Ltrs
0
Recalls
0
Refusals
Peer Rank: Ranks in the 68th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: Incoming Ingredient Identity Testing & COA Qualification
Primary Theme: Incoming Ingredient Identity Testing & COA Qualification
VA San Diego Healthcare Systems
BBB
70/100 · Moderate (VAI)
FEI: 2071629 · CA, United States
Pharmaceuticals & Sterile/OTC Drugs
VERIFIED CO-PACKER
1
483s
0
Warn Ltrs
0
Recalls
0
Refusals
Peer Rank: Ranks in the 36th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: Incoming Ingredient Identity Testing & COA Qualification
Primary Theme: Incoming Ingredient Identity Testing & COA Qualification
CD Pharmacy LLC dba Red Rock Pharmacy
BB
68/100 · Moderate (VAI)
FEI: 3032406608 · UT, United States
Pharmaceuticals & Sterile/OTC Drugs
VERIFIED CO-PACKER
1
483s
1
Warn Ltrs
0
Recalls
0
Refusals
Peer Rank: Ranks in the 25th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: Electronic Record Data Integrity (21 CFR Part 11) & Retention
Primary Theme: Electronic Record Data Integrity (21 CFR Part 11) & Retention
Strides Pharma Science Limited
BB
68/100 · Moderate (VAI)
FEI: 3004554612 · IN, India
Pharmaceuticals & Sterile/OTC Drugs
VERIFIED CO-PACKER
1
483s
0
Warn Ltrs
0
Recalls
1
Refusals
Peer Rank: Ranks in the 25th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: Master Manufacturing & Batch Production Records (MMR/BPR)
Primary Theme: Master Manufacturing & Batch Production Records (MMR/BPR)
Zhejiang Huahai Pharmaceutical Co., Ltd.
BB
68/100 · Moderate (VAI)
FEI: 3003999190 · CH, China
Pharmaceuticals & Sterile/OTC Drugs
VERIFIED CO-PACKER
1
483s
0
Warn Ltrs
0
Recalls
1
Refusals
Peer Rank: Ranks in the 25th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: CAPA, Out-of-Specification (OOS) & Complaint Investigations
Primary Theme: CAPA, Out-of-Specification (OOS) & Complaint Investigations
BPI Labs, LLC
BB
67/100 · Moderate (VAI)
FEI: 3015156709 · FL, United States
Pharmaceuticals & Sterile/OTC Drugs
VERIFIED CO-PACKER
1
483s
0
Warn Ltrs
0
Recalls
0
Refusals
Peer Rank: Ranks in the 14th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: Incoming Ingredient Identity Testing & COA Qualification
Primary Theme: Incoming Ingredient Identity Testing & COA Qualification
Perrigo New York, Inc.
BB
66/100 · Moderate (VAI)
FEI: 2450054 · NY, USA
Pharmaceuticals & Sterile/OTC Drugs
VERIFIED CO-PACKER
1
483s
0
Warn Ltrs
0
Recalls
1
Refusals
Peer Rank: Ranks in the 14th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: Cleaning Validation, Sanitation Logs & Pest Control
Primary Theme: Cleaning Validation, Sanitation Logs & Pest Control
Pfizer
BB
68/100 · Moderate (VAI)
FEI: FEI-59D52EE6 · NY, United States
Pharmaceuticals & Sterile/OTC Drugs
0
483s
0
Warn Ltrs
2
Recalls
0
Refusals
Peer Rank: Ranks in the 25th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: No Active 483 Themes
Primary Theme: No Active 483 Themes
Immacule Lifesciences Private Limited
A
80/100 · Moderate (VAI)
FEI: 3014210753 · IN, India
Pharmaceuticals & Sterile/OTC Drugs
1
483s
0
Warn Ltrs
0
Recalls
0
Refusals
Peer Rank: Ranks in the 73th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: Finished Product Testing, Stability & Expiration Dating
Primary Theme: Finished Product Testing, Stability & Expiration Dating
Fareva Amboise
A
80/100 · Moderate (VAI)
FEI: 3000234005 · FR, France
Pharmaceuticals & Sterile/OTC Drugs
1
483s
0
Warn Ltrs
0
Recalls
0
Refusals
Peer Rank: Ranks in the 73th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: Electronic Record Data Integrity (21 CFR Part 11) & Retention
Primary Theme: Electronic Record Data Integrity (21 CFR Part 11) & Retention
Center for Assisted Reproduction
A
80/100 · Moderate (VAI)
FEI: 3003926882 · TX, USA
Pharmaceuticals & Sterile/OTC Drugs
1
483s
0
Warn Ltrs
0
Recalls
0
Refusals
Peer Rank: Ranks in the 73th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: Label Control, Undeclared Allergens & Structure/Function Claims
Primary Theme: Label Control, Undeclared Allergens & Structure/Function Claims
Voila Juice Company
A
80/100 · Moderate (VAI)
FEI: FEI-0EEAC677 · CA, United States
Food & Beverage
NOINDEX (THIN)
0
483s
0
Warn Ltrs
1
Recalls
0
Refusals
Peer Rank: Ranks in the 85th percentile among Food & Beverage facilities.
Primary Theme: No Active 483 Themes
Primary Theme: No Active 483 Themes
Pacific Coast Producers
A
80/100 · Moderate (VAI)
FEI: FEI-DC2CDE01 · CA, United States
Food & Beverage
NOINDEX (THIN)
0
483s
0
Warn Ltrs
1
Recalls
0
Refusals
Peer Rank: Ranks in the 85th percentile among Food & Beverage facilities.
Primary Theme: No Active 483 Themes
Primary Theme: No Active 483 Themes
Trader Joe's Company
A
80/100 · Moderate (VAI)
FEI: FEI-F43B05E3 · CA, United States
Food & Beverage
NOINDEX (THIN)
0
483s
0
Warn Ltrs
1
Recalls
0
Refusals
Peer Rank: Ranks in the 85th percentile among Food & Beverage facilities.
Primary Theme: No Active 483 Themes
Primary Theme: No Active 483 Themes
Gearharts Fine Chocolates, Inc.
A
80/100 · Moderate (VAI)
FEI: FEI-17911345 · VA, United States
Food & Beverage
NOINDEX (THIN)
0
483s
0
Warn Ltrs
1
Recalls
0
Refusals
Peer Rank: Ranks in the 85th percentile among Food & Beverage facilities.
Primary Theme: No Active 483 Themes
Primary Theme: No Active 483 Themes
EVEXIAS HEALTH SOLUTION
A
80/100 · Moderate (VAI)
FEI: FEI-70FA0CFA · TX, United States
Dietary Supplements
NOINDEX (THIN)
0
483s
0
Warn Ltrs
1
Recalls
0
Refusals
Peer Rank: Ranks in the 50th percentile among Dietary Supplements facilities.
Primary Theme: No Active 483 Themes
Primary Theme: No Active 483 Themes
STRIDES PHARMA INC
A
80/100 · Moderate (VAI)
FEI: FEI-9609703B · NJ, United States
Pharmaceuticals & Sterile/OTC Drugs
NOINDEX (THIN)
0
483s
0
Warn Ltrs
1
Recalls
0
Refusals
Peer Rank: Ranks in the 73th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: No Active 483 Themes
Primary Theme: No Active 483 Themes
Hikma Pharmaceuticals USA INC.
A
80/100 · Moderate (VAI)
FEI: FEI-95060FDC · OH, United States
Pharmaceuticals & Sterile/OTC Drugs
NOINDEX (THIN)
0
483s
0
Warn Ltrs
1
Recalls
0
Refusals
Peer Rank: Ranks in the 73th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: No Active 483 Themes
Primary Theme: No Active 483 Themes
Shenzhen Techdow Pharmaceutical Co., Ltd.
A
80/100 · Moderate (VAI)
FEI: FEI-5B4DCDE8 · US, China
EPA / Specialty Chemical
NOINDEX (THIN)
0
483s
0
Warn Ltrs
1
Recalls
0
Refusals
Peer Rank: Ranks in the 88th percentile among EPA / Specialty Chemical facilities.
Primary Theme: No Active 483 Themes
Primary Theme: No Active 483 Themes
AvKARE
A
80/100 · Moderate (VAI)
FEI: FEI-D3A3D7EB · TN, United States
Pharmaceuticals & Sterile/OTC Drugs
NOINDEX (THIN)
0
483s
0
Warn Ltrs
1
Recalls
0
Refusals
Peer Rank: Ranks in the 73th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: No Active 483 Themes
Primary Theme: No Active 483 Themes
Ascend Laboratories, LLC
A
80/100 · Moderate (VAI)
FEI: FEI-8C979EC6 · NJ, United States
Pharmaceuticals & Sterile/OTC Drugs
NOINDEX (THIN)
0
483s
0
Warn Ltrs
1
Recalls
0
Refusals
Peer Rank: Ranks in the 73th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: No Active 483 Themes
Primary Theme: No Active 483 Themes
Life Technologies Holdings Pte Ltd
A
80/100 · Moderate (VAI)
FEI: FEI-34C21684 · US, Singapore
Medical Devices
NOINDEX (THIN)
0
483s
0
Warn Ltrs
1
Recalls
0
Refusals
Peer Rank: Ranks in the 93th percentile among Medical Devices facilities.
Primary Theme: No Active 483 Themes
Primary Theme: No Active 483 Themes
Greiner Bio-One North America, Inc.
A
80/100 · Moderate (VAI)
FEI: FEI-0C50B4FA · NC, United States
Medical Devices
NOINDEX (THIN)
0
483s
0
Warn Ltrs
1
Recalls
0
Refusals
Peer Rank: Ranks in the 93th percentile among Medical Devices facilities.
Primary Theme: No Active 483 Themes
Primary Theme: No Active 483 Themes
Medtronic MiniMed, Inc.
A
80/100 · Moderate (VAI)
FEI: FEI-763A04C8 · CA, United States
Cosmetics & Skincare
NOINDEX (THIN)
0
483s
0
Warn Ltrs
1
Recalls
0
Refusals
Peer Rank: Ranks in the 86th percentile among Cosmetics & Skincare facilities.
Primary Theme: No Active 483 Themes
Primary Theme: No Active 483 Themes
TECHNO-PATH MANUFACTURING LTD.
A
80/100 · Moderate (VAI)
FEI: FEI-02BA1115 · US, Ireland
Medical Devices
NOINDEX (THIN)
0
483s
0
Warn Ltrs
1
Recalls
0
Refusals
Peer Rank: Ranks in the 93th percentile among Medical Devices facilities.
Primary Theme: No Active 483 Themes
Primary Theme: No Active 483 Themes
Beckman Coulter, Inc.
A
80/100 · Moderate (VAI)
FEI: FEI-64C907EA · IN, United States
Medical Devices
NOINDEX (THIN)
0
483s
0
Warn Ltrs
1
Recalls
0
Refusals
Peer Rank: Ranks in the 93th percentile among Medical Devices facilities.
Primary Theme: No Active 483 Themes
Primary Theme: No Active 483 Themes
Medtronic Neuromodulation
A
80/100 · Moderate (VAI)
FEI: FEI-ED320B06 · MN, United States
Medical Devices
NOINDEX (THIN)
0
483s
0
Warn Ltrs
1
Recalls
0
Refusals
Peer Rank: Ranks in the 93th percentile among Medical Devices facilities.
Primary Theme: No Active 483 Themes
Primary Theme: No Active 483 Themes
Baystate Medical Center IRB
BBB
79/100 · Moderate (VAI)
FEI: 1283379 · MA, USA
Pharmaceuticals & Sterile/OTC Drugs
1
483s
0
Warn Ltrs
0
Recalls
0
Refusals
Peer Rank: Ranks in the 71th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: Incoming Ingredient Identity Testing & COA Qualification
Primary Theme: Incoming Ingredient Identity Testing & COA Qualification
Centrient Pharmaceuticals India Private Limited
BBB
79/100 · Moderate (VAI)
FEI: 3004497364 · IN, India
Pharmaceuticals & Sterile/OTC Drugs
1
483s
0
Warn Ltrs
0
Recalls
0
Refusals
Peer Rank: Ranks in the 71th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: Electronic Record Data Integrity (21 CFR Part 11) & Retention
Primary Theme: Electronic Record Data Integrity (21 CFR Part 11) & Retention
Jae S. Cho, M.D
BBB
79/100 · Moderate (VAI)
FEI: 3040335429 · OH, USA
Pharmaceuticals & Sterile/OTC Drugs
1
483s
0
Warn Ltrs
0
Recalls
0
Refusals
Peer Rank: Ranks in the 71th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
Primary Theme: Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
Gold Star Distribution Inc.
BBB
79/100 · Moderate (VAI)
FEI: 3004388746 · MN, USA
Pharmaceuticals & Sterile/OTC Drugs
1
483s
0
Warn Ltrs
0
Recalls
0
Refusals
Peer Rank: Ranks in the 71th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: Finished Product Testing, Stability & Expiration Dating
Primary Theme: Finished Product Testing, Stability & Expiration Dating
KEDPLASMA LLC
BBB
79/100 · Moderate (VAI)
FEI: 3024967183 · IN, USA
Pharmaceuticals & Sterile/OTC Drugs
1
483s
0
Warn Ltrs
0
Recalls
0
Refusals
Peer Rank: Ranks in the 71th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: Personnel GMP Training, Gowning & Hygienic Practices
Primary Theme: Personnel GMP Training, Gowning & Hygienic Practices
Sauna Works, Inc
BBB
79/100 · Moderate (VAI)
FEI: 3013870241 · CA, USA
Pharmaceuticals & Sterile/OTC Drugs
1
483s
0
Warn Ltrs
0
Recalls
0
Refusals
Peer Rank: Ranks in the 71th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: Electronic Record Data Integrity (21 CFR Part 11) & Retention
Primary Theme: Electronic Record Data Integrity (21 CFR Part 11) & Retention
Gland Chemicals Private Limited
BBB
79/100 · Moderate (VAI)
FEI: 3008386908 · IN, India
EPA / Specialty Chemical
1
483s
0
Warn Ltrs
0
Recalls
0
Refusals
Peer Rank: Ranks in the 75th percentile among EPA / Specialty Chemical facilities.
Primary Theme: Incoming Ingredient Identity Testing & COA Qualification
Primary Theme: Incoming Ingredient Identity Testing & COA Qualification
SCA Pharmaceuticals Inc
BBB
79/100 · Moderate (VAI)
FEI: 3010683157 · AR, United States
Pharmaceuticals & Sterile/OTC Drugs
1
483s
0
Warn Ltrs
0
Recalls
0
Refusals
Peer Rank: Ranks in the 71th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: Cleaning Validation, Sanitation Logs & Pest Control
Primary Theme: Cleaning Validation, Sanitation Logs & Pest Control
Inotiv Inc.
BBB
79/100 · Moderate (VAI)
FEI: 1000140135 · UN, United States
Pharmaceuticals & Sterile/OTC Drugs
1
483s
0
Warn Ltrs
0
Recalls
0
Refusals
Peer Rank: Ranks in the 71th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Primary Theme: Master Manufacturing & Batch Production Records (MMR/BPR)
Primary Theme: Master Manufacturing & Batch Production Records (MMR/BPR)
High-Intent Industry & Regional Intelligence Hubs
Built with structured facts, dates, and government source links to earn citations in Google AI Overviews, ChatGPT, and Perplexity.
Dietary Supplements (21 CFR Part 111)
Most-Cited FDA Form 483 Problems for Dietary Supplement Makers (2026)
Cross-database analysis of the top 21 CFR Part 111 observations issued to capsule, gummy, powder, and botanical contract manufacturers, led by 21 CFR 111.75(a)(1) incoming ingredient identity testing and 21 CFR 111.205 Master Manufacturing Records.
Run an AI Mock Inspection against 21 CFR Part 111 →Regional Facility Intelligence (Texas)
FDA-Regulated Manufacturers & Form 483 Inspections in Texas
Complete map of Texas supplement, food, chemical, pharmaceutical, and medical device facilities, including recent Form 483 observations, NAI clean-record co-packers, and warning letters.
Find a Verified Clean-Record Co-Packer in Texas →Regional Facility Intelligence (California)
FDA-Regulated Manufacturers & Form 483 Inspections in California
Facility compliance records, cosmetic MoCRA registrations, supplement co-packers, and recent FDA ORA Pacific Southwest inspection findings across California.
Watch California Suppliers for Free →Cosmetics & Skincare (MoCRA / OTC)
Cosmetic & Skincare Contract Manufacturers — MoCRA & FDA Record Guide
How to vet skincare, serum, and OTC sunscreen contract manufacturers using FDA inspection records, recalls, import refusals, and MoCRA serious adverse event filings.
Match with Clean-Record Cosmetic Co-Packers →Food & Beverage (21 CFR Part 117)
Food & Beverage Co-Packers: 21 CFR Part 117 & FSVP Inspection Benchmarks
Ranking food and RTD beverage co-packers on sanitation (21 CFR 117.35), allergen controls, Foreign Supplier Verification (21 CFR 1.502), and Class I/II recall history.
Request Quotes from Clean-Record Food Co-Packers →Global Supply Chain & Import Alerts
Foreign Supplier FDA Import Refusals & Red List Tracker
Track foreign API, ingredient, supplement, and medical device factories whose shipments were detained without physical examination (DWPE) at U.S. ports of entry.
Monitor Your Foreign Suppliers for Border Refusals →