FDA Inspection
Pace Analytical Inc.Pace Analytical Inc. – FDA Inspection, Mar 21, 2024
Record Details
This FDA Inspection record concerns Pace Analytical Inc., with an inspection on March 21, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Person
- Jeremy L. Wally (Issuing Officer)
View Company Profile
ID · 60e1a9b9-f053-4c3f-bd77-efda5e995f0d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1233590
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pace Analytical Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2025 | VAI | San Juan District Office | Drug Quality Assurance |
| 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 1277699 - 2025-08-07
- FDA Inspection 1074711 - 2018-11-09
- FDA Inspection 935215 - 2015-07-09
- FDA Inspection 805448 - 2012-10-31
- FDA Inspection 742959 - 2011-09-06
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.