FDA Inspection 1112266 — BayCare Integrated Service Center LLC
The FDA completed an inspection of BayCare Integrated Service Center LLC on Dec 10, 2019 in Temple Terrace, 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: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 10, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Temple Terrace, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 21284 | FDCA 501(a)(2)(A) | Disinfectant contact time |