FDA Inspection 1233334 — KVK Tech, Inc.
The FDA completed an inspection of KVK Tech, Inc. on March 14, 2025 in Newtown, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 14, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Newtown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |