FDA Inspection 1225831 — Shri Kartikeya Pharma
The FDA completed an inspection of Shri Kartikeya Pharma on Dec 22, 2023 in Jadcherla. 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). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 22, 2023
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Jadcherla (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 18154 | 21 CFR 117.80(a)(2) | Appropriate quality control operations |
| 19045 | 21 CFR 117.160(a) | Process controls - Validation |
| 22702 | 21 CFR 117.135(a)(1) | Process preventive controls - Identify (Written) |
| 22705 | 21 CFR 117.135(a)(1) | Allergen preventive controls - Identify (Written) |