FDA Inspection 683732 — RWM Technologies LLC
The FDA completed an inspection of RWM Technologies LLC on October 4, 2010 in Chattanooga, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 4, 2010
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Chattanooga, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4367 | 21 CFR 211.188(b)(13) | Examinations for correct labeling |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4374 | 21 CFR 211.188(b)(6) | Inspection of packaging and labeling area |
| 4379 | 21 CFR 211.188(b)(1) | Dates not included for each significant step |