FDA Inspection 1206133 — Oversea Production Sdn. Bhd.
The FDA completed an inspection of Oversea Production Sdn. Bhd. on May 16, 2023 in Shah Alam. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 16, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Shah Alam (Malaysia)
Citations
| ID | CFR | Description |
|---|---|---|
| 18400 | 21 CFR 117.315 | Record retention |
| 19083 | 21 CFR 117.180(d) | PCQI training records |
| 22701 | 21 CFR 117.130(a)(1) | Hazard analysis - Conducted |
| 22704 | 21 CFR 117.190(a) | Process preventive controls - Implementation records |
| 22710 | 21 CFR 117.190(a) | Sanitation preventive controls - Implementation records |
| 22717 | 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard |