FDA Inspection 1209453 — Arizona Center For Reproductive Endocrinology & Infertility
The FDA completed an inspection of Arizona Center For Reproductive Endocrinology & Infertility on Jun 28, 2023 in Tucson, AZ. 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). 7 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 28, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Tucson, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |