FDA Inspection
Carolina Conceptions, PACarolina Conceptions, PA – FDA Inspection, Jun 1, 2023
Record Details
This FDA Inspection record concerns Carolina Conceptions, PA, with an inspection on June 1, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · fa3a5da7-5a94-42ab-93e7-cd553b8bf9a6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1207709
- 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 1271.65(b)(2)Labeled re: biohazard, risks, test results
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Other FDA inspections of Carolina Conceptions, PA
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 20, 2021 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 21, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 23, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 23, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Carolina Conceptions, PA
- FDA Inspection 1258934 - 2025-01-16
- FDA Inspection 1150309 - 2021-08-20
- FDA Inspection 1042451 - 2018-02-21
- FDA Inspection 974333 - 2016-06-23
- FDA Inspection 896812 - 2014-09-23
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