FDA Inspection 1034994 — Kath Khemicals LLC
The FDA completed an inspection of Kath Khemicals LLC on December 14, 2017 in Macomb, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 14, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Macomb, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |