FDA Inspection
PharmPak, Inc.PharmPak, Inc. – FDA Inspection, Dec 9, 2021
Record Details
This FDA Inspection record concerns PharmPak, Inc., with an inspection on December 9, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- PharmPak, Inc.
- Inspection Date
- December 9, 2021
- Product Type
- Drugs
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ID · 47a0770b-9631-4f6a-9b92-948001c17f5b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1158404
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.46(d)Penicillin air handling systems not kept separate
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of PharmPak, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 17, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 23, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 18, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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