FDA Inspection 974374 — SARL Tahitian Import Export
The FDA completed an inspection of SARL Tahitian Import Export on May 4, 2016 in Punaauia. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 4, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Punaauia (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15660 | 21 CFR 111.475(b)(2) | Records - product distribution |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 16037 | 21 CFR 111.605 | Records - keep: 1 year, 2 years |
| 9930 | 21 CFR 120.6(c) | SSOP records |
| 9931 | 21 CFR 120.6(b) | Sanitation monitoring |
| 9932 | 21 CFR 120.6(a) | Sanitation SSOP - none or not implemented |
| 9935 | 21 CFR 120.7(a) | No hazard analysis |
| 9941 | 21 CFR 120.8(a) | No HACCP plan |