FDA Inspection 1061558 — Specialists In Reproductive Medicine & Surgery, P.A.
The FDA completed an inspection of Specialists In Reproductive Medicine & Surgery, P.A. on Aug 9, 2018 in Fort Myers, 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). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 9, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Fort Myers, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 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 |
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12280 | 21 CFR 1271.75(c) | Reproductive cells/ tissues- general |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |