FDA Inspection 840180 — Gasco Industrial Corp.
The FDA completed an inspection of Gasco Industrial Corp. on July 2, 2013 in Gurabo, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 2, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gurabo, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1126 | 21 CFR 110.40(a) | Precluding contaminants |
| 1287 | 21 CFR 110.20(a)(1) | Harborage areas |
| 1554 | 21 CFR 110.35(a) | Cleaning and sanitizing operations |
| 1556 | 21 CFR 110.35(b)(2) | Storage requirements |
| 1695 | 21 CFR 110.80(b)(2) | Manufacturing conditions |
| 2393 | 21 CFR 110.80(b)(1) | Teardown equipment/thorough cleaning |