FDA Inspection 928839 — Luen Fook Medicine Sdn. Bhd.
The FDA completed an inspection of Luen Fook Medicine Sdn. Bhd. on May 22, 2015 in Johor Bahru. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 22, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Johor Bahru (Malaysia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1371 | 21 CFR 211.101(a) | Batches Formulated to less than 100% |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |