FDA Inspection 1214709 — Thai Nakorn Patana Co., Ltd,
The FDA completed an inspection of Thai Nakorn Patana Co., Ltd, on August 4, 2023 in Mueang Nonthaburi. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 4, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mueang Nonthaburi (Thailand)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4410 | 21 CFR 211.194(a)(5) | Calculations performed are in the records |