FDA Inspection 973822 — Crown Laboratories
The FDA completed an inspection of Crown Laboratories on Apr 8, 2016 in Johnson City, TN. 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
- Apr 8, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Johnson City, TN (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 1 | 21 CFR 11 | Electronic records |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |
| 6706 | 21 CFR 310.305(c)(1)(i) | Late submission |
| 8935 | FDCA 760(b)(1) | Failure of responsible person to report AE (non-RX Drug) |