FDA Inspection 983189 — Gasco Industrial Corp.
The FDA completed an inspection of Gasco Industrial Corp. on July 6, 2016 in Gurabo, PR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 6, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Gurabo, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1126 | 21 CFR 110.40(a) | Precluding contaminants |
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 1287 | 21 CFR 110.20(a)(1) | Harborage areas |
| 1306 | 21 CFR 110.20(b)(7) | Screening |
| 1554 | 21 CFR 110.35(a) | Cleaning and sanitizing operations |
| 1556 | 21 CFR 110.35(b)(2) | Storage requirements |
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 1562 | 21 CFR 110.35(d) | Failure to clean - general |
| 1695 | 21 CFR 110.80(b)(2) | Manufacturing conditions |
| 2386 | 21 CFR 110.80(a)(1) | Storage |
| 3062 | 21 CFR 114.10 | Personnel |
| 3075 | 21 CFR 114.80(a)(4) | Container testing |
| 3078 | 21 CFR 114.80(b) | Code - required elements |
| 3658 | 21 CFR 110.37(e)(2) | Hand cleaning and sanitizing preparations |
| 4464 | 21 CFR 108.25(c)(1) | Registration |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |