FDA Inspection 1245775 — Piedmont Reproductive Endocrinology Associates Lowcountry
The FDA completed an inspection of Piedmont Reproductive Endocrinology Associates Lowcountry on Aug 7, 2024 in Summerville, SC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 7, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Summerville, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12283 | 21 CFR 1271.75(e) | Abbreviated procedure |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |