FDA Inspection 1048798 — Polcz Fertility Lab, LLC
The FDA completed an inspection of Polcz Fertility Lab, LLC on Apr 19, 2018 in Boynton Beach, FL. 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 19, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Boynton Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12236 | 21 CFR 1271.55(a)(2) | Eligibility statement--basis of determination |
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |