FDA Inspection 1180998 — Massey Fertility Services
The FDA completed an inspection of Massey Fertility Services on Sep 22, 2022 in Atlanta, GA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 22, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Atlanta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 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 |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12290 | 21 CFR 1271.80(d)(1) | Reactive tests--not determined ineligible |