FDA Inspection
Pace Analytical Inc.Pace Analytical Inc. – FDA Inspection, Aug 7, 2025
Record Details
This FDA Inspection record concerns Pace Analytical Inc., with an inspection on August 7, 2025, issued by the San Juan District Office, covering human drugs.
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ID · d6fa066c-cc20-4ff9-987a-c1266e45d702
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1277699
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)(3)Drug products-sampling procedures/specifications
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Other FDA inspections of Pace Analytical Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| July 9, 2015 | 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 1233590 - 2024-03-21
- FDA Inspection 1074711 - 2018-11-09
- FDA Inspection 935215 - 2015-07-09
- FDA Inspection 805448 - 2012-10-31
- FDA Inspection 742959 - 2011-09-06
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