FDA Inspection 832692 — Diamondback Drugs Of Delaware, LLC
The FDA completed an inspection of Diamondback Drugs Of Delaware, LLC on May 17, 2013 in Scottsdale, AZ. 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). 9 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 17, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Scottsdale, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |
| 4576 | 21 CFR 211.192 | No written record of investigation |