FDA Inspection 1101668 — PUERTOMAR S.A
The FDA completed an inspection of PUERTOMAR S.A on Sep 11, 2019 in Jaramijo. 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). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 11, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Jaramijo (Ecuador)
Citations
| ID | CFR | Description |
|---|---|---|
| 1040 | 21 CFR 113.10 | Operators |
| 1500 | 21 CFR 113.89 | Evaluation by process authority |
| 1529 | 21 CFR 113.89 | Process deviation log/file |
| 16307 | 21 CFR 113.40(a)(8) | Still steam retorts: Bleeder not wide open during process |
| 16308 | 21 CFR 113.40(a)(1)(iv) | Still steam retorts: TID not accurate to 1 °F |
| 16313 | 21 CFR 113.40(a)(1) | RD accuracy test frequency |
| 1639 | 21 CFR 113.100(b) | Entry not timely |
| 1660 | 21 CFR 113.40(a)(1)(v) | TID not reference instrument |
| 4068 | 21 CFR 113.40(a)(4) | Maintenance of steam activated controller |