FDA Inspection
Athea Laboratories, Inc.Athea Laboratories, Inc. – FDA Inspection, Mar 16, 2011
Record Details
This FDA Inspection record concerns Athea Laboratories, Inc., with an inspection on March 16, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Athea Laboratories, Inc.
- Inspection Date
- March 16, 2011
- Product Type
- Drugs
View Company Profile
ID · 697f3bc7-15b2-4537-a37e-93fb20cc1ce5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 714571
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.134(a)Correct labels during finishing operations
- 21 CFR 211.67(b)(6)Cleaning SOP/inspection
- 21 CFR 211.42(c)(2)Rejected Material Area
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Athea Laboratories, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 14, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 12, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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