FDA Inspection 1026851 — Citra Labs, LLC
The FDA completed an inspection of Citra Labs, LLC on September 27, 2017 in Braintree, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 27, 2017
- Fiscal Year
- 2017
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Braintree, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |