FDA Inspection 1001723 — Tropichem Research Labs LLC
The FDA completed an inspection of Tropichem Research Labs LLC on Feb 14, 2017 in Jupiter, 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). 7 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 14, 2017
- Fiscal Year
- 2017
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Jupiter, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2004 | 21 CFR 211.184(d) | Labeling: documentation of exam and review |