FDA Inspection 1205031 — VIT MAKANAN (KUALA LUMPUR) SDN BHD
The FDA completed an inspection of VIT MAKANAN (KUALA LUMPUR) SDN BHD on May 12, 2023 in Rawang. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 12, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Rawang (Malaysia)
Citations
| ID | CFR | Description |
|---|---|---|
| 18141 | 21 CFR 117.35(a) | Sanitary operations - Plant maintenance |
| 18148 | 21 CFR 117.37 | Sanitary facilities and controls |
| 18399 | 21 CFR 117.305 | Training records - General requirements |
| 19083 | 21 CFR 117.180(d) | PCQI training records |
| 22704 | 21 CFR 117.190(a) | Process preventive controls - Implementation records |
| 22717 | 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard |
| 22719 | 21 CFR 117.135(c)(2) | Allergen preventive controls - Appropriate (Adequate) |
| 22722 | 21 CFR 117.405(a)(1) | Supply-chain program - Establish |
| 3075 | 21 CFR 114.80(a)(4) | Container testing |
| 3078 | 21 CFR 114.80(b) | Code - required elements |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 3085 | 21 CFR 114.100(a) | Raw materials, packaging, finished product |
| 4464 | 21 CFR 108.25(c)(1) | Registration |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |
| 4511 | 21 CFR 108.25(f) | Approved school |