FDA Inspection 1250188 — Haw Par Healthcare Limited
The FDA completed an inspection of Haw Par Healthcare Limited on September 27, 2024 in Singapore. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 27, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Singapore (Singapore)
Citations
| ID | CFR | Description |
|---|---|---|
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2621 | 21 CFR 211.198(b)(3) | Reason for Not Conducting Complaint Investigation |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |