FDA Inspection
Pace Analytical Inc.Pace Analytical Inc. – FDA Inspection, Jul 9, 2015
Record Details
This FDA Inspection record concerns Pace Analytical Inc., with an inspection on July 9, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pace Analytical Inc.
- Inspection Date
- July 9, 2015
- Product Type
- Drugs
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ID · d9ffbee9-7839-49f3-aee6-08bffd4d89ee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 935215
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(a)Lab controls established, including changes
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Other FDA inspections of Pace Analytical Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2025 | VAI | San Juan District Office | Drug Quality Assurance |
| March 21, 2024 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 9, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 31, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 6, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pace Analytical Inc.
- FDA Inspection 1277699 - 2025-08-07
- FDA Inspection 1233590 - 2024-03-21
- FDA Inspection 1074711 - 2018-11-09
- FDA Inspection 805448 - 2012-10-31
- FDA Inspection 742959 - 2011-09-06
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