FDA Inspection 805646 — Kath Khemicals LLC
The FDA completed an inspection of Kath Khemicals LLC on November 1, 2012 in Macomb, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 1, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Macomb, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 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 |