FDA Inspection
AnuMed International LLCAnuMed International LLC – FDA Inspection, Dec 13, 2017
Record Details
This FDA Inspection record concerns AnuMed International LLC, with an inspection on December 13, 2017, issued by the Denver District Office, covering foods & cosmetics.
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ID · c2a41ad7-f250-4d1e-b85e-64f0d223c78f
Inspection Facts
- Inspection number
- 1036129
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.170(b)Reserve drug product sample quantity - all tests
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of AnuMed International LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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