Enemeez LLC
Registered Address: Arizona, USA (USA)
5 Questions to Ask Enemeez LLC 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: On 2026-02-12, FDA cited 21 CFR 212.20(c) (Incoming Ingredient Identity Testing & COA Qualification). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q2: On 2026-02-12, FDA cited 21 CFR 212.70(c) (Master Manufacturing & Batch Production Records (MMR/BPR)). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q3: On 2026-02-12, FDA cited 21 CFR 314.80(c)(2)(ii)(B) (Electronic Record Data Integrity (21 CFR Part 11) & Retention). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q4: 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?
- Q5: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI 3005641023?
Cross-Database Regulatory & Inspection Timeline
Unified chronological history across FDA ORA Inspections, Form 483s, Warning Letters, Enforcement Recalls, and OASIS Import Refusals.
FDA Form 483 issued to Enemeez LLC (FEI 3005641023) on 2026-02-12 following an inspection of its manufacturer operations in Arizona. The report documents 4 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Master Manufacturing & Batch Production Records (MMR/BPR).
- 21 CFR 212.20(c) (Incoming Ingredient Identity Testing & COA Qualification): Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier. REPEAT OBSERVATION
- 21 CFR 212.70(c) (Master Manufacturing & Batch Production Records (MMR/BPR)): Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
- 21 CFR 314.80(c)(2)(ii)(B) (Electronic Record Data Integrity (21 CFR Part 11) & Retention): Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
- 21 CFR 211.28(a) (Personnel GMP Training, Gowning & Hygienic Practices): Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
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.
6-Subsystem cGMP Radar Breakdown
Sub-scores mapped across FDA's six core inspection subsystems.
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Score Provenance Receipts
Every point in this facility's FDA Record Index (71/100) is backed by a linked government record (36-month half-life decay).
| Event | Date | Weight | Receipt |
|---|---|---|---|
| Inspection Outcome (VAI) | 2026-02-12 | -8.5 pts | INSP-483-3005641023-20260212 ↗ |
| Form 483 (4 observations, 1 repeat) | 2026-02-12 | -12.7 pts | 483-3005641023-20260212 ↗ |