INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Cosmetics & Skincare
FEI: FEI-D265EF96
🛡️ LEVEL 0 · PAPER REGISTRATION ONLY
PRITAM INTERNATIONAL PRIVATE LIMITED
Registered Address: Khasra No. 138, Raipur Industrial Area, Haridwar, US (India)
For Brand Buyers: PRITAM INTERNATIONAL PRIVATE LIMITED carries a CCC (12/100) rating due to documented FDA activity centered on cGMP documentation controls. Before wiring a deposit, require written proof of CAPA closure and third-party ISO 17025 finished-batch release testing.
Connected FDA Sources (1): openFDA Enforcement Reports
· Resolved Name Aliases: PRITAM INTERNATIONAL PRIVATE LIMITED
CCC
12/100
Elevated Citations
7-Dim FDA Record Index v2.0
More recent FDA citations than 86% of tracked Cosmetics & Skincare facilities.
Based strictly on public U.S. FDA records as of 2026-11-03. See Formula v2.0
Dim 1 · Credit Grade
CCC (12/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 0 / 4
Registered in FDA Database — Zero Physical FDA Inspections Recorded
Dim 4 · 'Elsa' Audit Odds
74%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
4%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
5 Brands
~25 Downstream SKUs
LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT
Tailored to FEI FEI-D265EF96's FDA Record
5 Questions to Ask PRITAM INTERNATIONAL PRIVATE LIMITED Before Signing a Manufacturing Contract
Bring these exact questions to your discovery call with their QA Director or account rep before wiring a production deposit:
- Q1: Regarding Recall D-0062-2027 (Class II on 2026-10-28), what line-clearance or preventive control changes were implemented to prevent recurrence?
- Q2: Since FDA databases show an electronic registration without a recorded physical FDA inspection, can you provide your most recent third-party SQF, UL, NSF, or ISO cGMP audit report?
- Q3: Do you perform 100% FTIR/HPLC identity testing on incoming active ingredients in-house (21 CFR 111.75(a)(1)), or do you rely on vendor COAs?
- Q4: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI FEI-D265EF96?
- Q5: Can we review a redacted Master Manufacturing Record (MMR) and Batch Production Record (BPR) with dual-operator weight verification and yield reconciliation?
Cross-Database Regulatory & Inspection Timeline
Unified chronological history across FDA ORA Inspections, Form 483s, Warning Letters, Enforcement Recalls, and OASIS Import Refusals.
FDA Enforcement Recall (Class II · D-0062-2027) · 2026-10-28
View Recall Notice →
Product: Brush Buddies, Mint Chocolate Chip Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-520-35, Item # 88520, UPC 8 10147 88520 6
Reason: CGMP Deviations.
FDA Enforcement Recall (Class II · D-0060-2027) · 2026-10-28
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Product: evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%, sodium fluoride 0.24%) Sweet Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-620-35, Item # 88620 UPC8 10147 88620 3
Reason: CGMP Deviations.
FDA Enforcement Recall (Class II · D-0056-2027) · 2026-10-28
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Product: Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride0.243%) Watermelon Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-004-40, Item # Product code: 32730, UPC 8 50048 32730 6.
Reason: CGMP Deviations.
FDA Enforcement Recall (Class II · D-0067-2027) · 2026-10-28
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Product: BB (Brush Buddies) Advanced Whitening, Anti-Cavity Fluoride Toothpaste, (sodium fluoride 0,24%) Peppermint, Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-885-42, Item # 88542, UPC 8 10147 88542 8
Reason: CGMP Deviations.
FDA Enforcement Recall (Class II · D-0058-2027) · 2026-10-28
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Product: Brush Buddies, My Little Pony Scents Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-008-40, Item# 88270, UPC 8 10147 88270 0.
Reason: CGMP Deviations.
FDA Enforcement Recall (Class II · D-0066-2027) · 2026-10-28
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Product: BB (Brush Buddies) Cavity Protection, Anti-Cavity Fluoride Toothpaste, (sodium monofluorophosphate 0.76%) Cool Mint, 2 Value Pack, Two 3.5 oz (99g) tubes, Total Net Wt 7 oz (198g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-035-10, Item # 88543, UPC
Reason: CGMP Deviations.
FDA Enforcement Recall (Class II · D-0054-2027) · 2026-10-28
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Product: Brush Buddies, Hot Wheels, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-002-40, Item # 88047, UPC 8 10147 88047 8
Reason: CGMP Deviations.
FDA Enforcement Recall (Class II · D-0057-2027) · 2026-10-28
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Product: Brush Buddies, Crayola Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-005-40, Item # 32732, UPC 8 50048 32732 0
Reason: CGMP Deviations.
FDA Enforcement Recall (Class II · D-0068-2027) · 2026-10-28
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Product: ARU, Toothpaste, Gum Health, 9 Ingredients, Soothing Mint, (stannous fluoride 0.45%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-786-35, Item # 88786 UPC 8 10147 88786 6
Reason: CGMP Deviations.
FDA Enforcement Recall (Class II · D-0064-2027) · 2026-10-28
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Product: Brush Buddies, Chocolate Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-518-35, Item # 88518, UPC 8 10147 88518 3
Reason: CGMP Deviations.
FDA Enforcement Recall (Class II · D-0059-2027) · 2026-10-28
View Recall Notice →
Product: evo, Advanced Whitening, Anticavity Fluoride Toothpaste, (sodium fluoride 0.24%) Peppermint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-886-19, Item# 88619, UPC 8 10147 88619 7
Reason: CGMP Deviations.
FDA Enforcement Recall (Class II · D-0069-2027) · 2026-10-28
View Recall Notice →
Product: ARU, Toothpaste, Cavity Protection, 9 Ingredients, Cool Mint, (sodium fluoride 0.243%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-785-35, Item # 88785, UPC 8 10147 88785
Reason: CGMP Deviations.
FDA Enforcement Recall (Class II · D-0061-2027) · 2026-10-28
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Product: Brush Buddies, Vanilla Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-517-35, Item # 88517, UPC 8 10147 88517 6
Reason: CGMP Deviations
FDA Enforcement Recall (Class II · D-0053-2027) · 2026-10-28
View Recall Notice →
Product: Brush Buddies, Barbie, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-001-40, Item# 88022, UPC 8 10147 88022 5
Reason: CGMP Deviations
FDA Enforcement Recall (Class II · D-0055-2027) · 2026-10-28
View Recall Notice →
Product: Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-003-40, Item # 32731, UPC 8 50048 32731 3
Reason: CGMP Deviations
FDA Enforcement Recall (Class II · D-0065-2027) · 2026-10-28
View Recall Notice →
Product: Brush Buddies, Whitening Anti-cavity Fluoride Toothpaste, with Baking Soda, (sodium monofluorophosphate 0.76%) Cool Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-007-07, ITEM # 999131, 8 50010 84249 3
Reason: CGMP Deviations.
FDA Enforcement Recall (Class II · D-0063-2027) · 2026-10-28
View Recall Notice →
Product: Brush Buddies, Cookies 'n Cream Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-519-35, Item # 88519, UPC 8 10147 88519 0
Reason: CGMP Deviations.
Manufacturer Right-of-Reply & Free Match Correction
GUARDRAIL PROTECTEDTo ensure fairness and accuracy, facility owners may submit verified Form 483 closeout evidence, CAPA completion statements, or entity-resolution corrections free of charge. Sponsorship never alters an FDA Record Index score.
Dimension 3 · FDA 6-System Model
6-Subsystem cGMP Radar Breakdown
Sub-scores mapped across FDA's six core inspection subsystems.
Quality System (CAPA & OOS)
15/100
Materials & Incoming Identity
13/100
Production & Batch Records
14/100
Facilities, Sanitation & Pest
16/100
Laboratory & Stability Controls
13/100
Packaging & Allergen Labeling
17/100
Layer 6 · Clean-Record Sourcing Alternatives
Verified AAA/AA Co-Packers in This Sector
Compare or request quotes from top-rated contract manufacturers with clean FDA inspection histories:
Pacific Dermaceutical & Clean Beauty Labs Inc. (CA)
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Grade AAA · 99/100 Clean Record
Score Provenance Receipts
Every point in this facility's FDA Record Index (12/100) is backed by a linked government record (36-month half-life decay).
| Event | Date | Weight | Receipt |
|---|---|---|---|
| Recall (Class II) | 2026-10-28 | -12.0 pts | D-0062-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | D-0060-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | D-0056-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | D-0067-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | D-0058-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | D-0066-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | D-0054-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | D-0057-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | D-0068-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | D-0064-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | D-0059-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | D-0069-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | D-0061-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | D-0053-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | D-0055-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | D-0065-2027 ↗ |
| Recall (Class II) | 2026-10-28 | -12.0 pts | D-0063-2027 ↗ |