FDA Inspection
AMMD Labs, LLCAMMD Labs, LLC – FDA Inspection, Sep 14, 2018
Record Details
This FDA Inspection record concerns AMMD Labs, LLC, with an inspection on September 14, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ada40184-ad1f-44d5-9c29-dd9fe7240971
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1065595
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
17- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.130(b)Unlabeled filled containers controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.25(c)Inadequate number of personnel
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Other FDA inspections of AMMD Labs, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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