Company
United StatesPace Analytical Inc., San German, PR – FDA Inspections
Inspection records and compliance data for Pace Analytical Inc. in San German, Puerto Rico. 7 FDA inspections on record, 2 Form 483s, last inspected August 07, 2025.
Company Profile
This profile covers Pace Analytical Inc. based in San German, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 5
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected June 26, 2009. Last inspected August 7, 2025.
Most cited issue areas
- Drug products-sampling procedures/specifications1 inspection
- Following/documenting laboratory controls1 inspection
- Lab controls established, including changes1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 7, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1277699 |
| March 21, 2024 | VAI | Biologics · Blood and Blood Products | 1233590 |
| November 9, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1074711 |
| July 9, 2015 | VAI | Human Drugs · Drug Quality Assurance | 935215 |
| October 31, 2012 | NAI | Human Drugs · Drug Quality Assurance | 805448 |
| September 6, 2011 | NAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 742959 |
| June 26, 2009 | VAI | Human Drugs · Drug Quality Assurance | 592549 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Pace Analytical Inc.
FEI Number
2623531
Address
Industrial Zone El Retiro Calle B And C, San German, Puerto Rico 00683, United States
Country
United States
ID: 1e82a50b-b20e-47d9-9b79-b9d6ad11b770