FDA Inspection 1181810 — Pan Rajdhevee Group Public Company Limited
The FDA completed an inspection of Pan Rajdhevee Group Public Company Limited on October 21, 2022 in Bangplee. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 21, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bangplee (Thailand)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |