FDA Inspection 1265697 — Kath Khemicals LLC
The FDA completed an inspection of Kath Khemicals LLC on April 3, 2025 in Macomb, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 3, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Macomb, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |