FDA Inspection
Pace Analytical ServicesPace Analytical Services – FDA Inspection, May 23, 2024
Record Details
This FDA Inspection record concerns Pace Analytical Services, with an inspection on May 23, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ee2a6a0b-f6b8-4ab9-9b01-07c33a908866
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1239312
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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Other FDA inspections of Pace Analytical Services
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 5, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pace Analytical Services
- FDA Inspection 998361 - 2017-01-05
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