FDA Inspection 997374 — PACETOL S.A
The FDA completed an inspection of PACETOL S.A on Nov 16, 2016 in Guayaquil. 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). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 16, 2016
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Guayaquil (Ecuador)
Citations
| ID | CFR | Description |
|---|---|---|
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 6005 | 21 CFR 123.6(c)(6) | Verification procedures - adequacy |
| 6008 | 21 CFR 123.8(a)(3) | Verification - record review - frequency |
| 933 | 21 CFR 123.8(a)(2)(ii) | Calibration - adequacy |