FDA Inspection
Piedmont Reproductive Endocrinology Associates LowcountryPiedmont Reproductive Endocrinology Associates Lowcountry – FDA Inspection, Aug 7, 2024
Record Details
This FDA Inspection record concerns Piedmont Reproductive Endocrinology Associates Lowcountry, with an inspection on August 7, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 7, 2024
- Product Type
- Biologics
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ID · f78cfc77-8faf-428a-bf5b-eaa735ec2101
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1245775
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.75(e)Abbreviated procedure
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Other FDA inspections of Piedmont Reproductive Endocrinology Associates Lowcountry
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
Other documents for Piedmont Reproductive Endocrinology Associates Lowcountry
- FDA Inspection 1164680 - 2022-03-07
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