FDA Inspection 1172846 — Polcz Fertility Lab, LLC
The FDA completed an inspection of Polcz Fertility Lab, LLC on Jun 27, 2022 in Boynton Beach, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 27, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Boynton Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |