FDA Inspection
Pacific Reproductive Center, Inc.Pacific Reproductive Center, Inc. – FDA Inspection, Aug 31, 2023
Record Details
This FDA Inspection record concerns Pacific Reproductive Center, Inc., with an inspection on August 31, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
View Company Profile
ID · de68d596-365d-4f0a-bb58-b2f4edcbd15b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1216495
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.50(a)Determination based on screening and testing
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pacific Reproductive Center, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 19, 2024 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 15, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 6, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 18, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 3, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Pacific Reproductive Center, Inc.
- FDA Inspection 1247061 - 2024-08-19
- FDA Inspection 1041285 - 2018-02-15
- FDA Inspection 933297 - 2015-07-06
- FDA Inspection 810928 - 2012-12-18
- FDA Inspection 722575 - 2011-05-03
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.