FDA Inspection 822982 — D'Arcy Acquisition, LLC., D.B.A. D'Arcy Laboratories
The FDA completed an inspection of D'Arcy Acquisition, LLC., D.B.A. D'Arcy Laboratories on Mar 12, 2013 in Pompano Beach, 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 12, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pompano Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |