FDA Inspection 1118725 — SGF Tampa Bay LLC
The FDA completed an inspection of SGF Tampa Bay LLC on Feb 24, 2020 in Tampa, 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). 7 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 24, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 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 |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |