FDA Inspection 619354 — PreMark Health Science, Inc.
The FDA completed an inspection of PreMark Health Science, Inc. on October 14, 2009 in Irving, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 14, 2009
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Irving, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1126 | 21 CFR 110.40(a) | Precluding contaminants |
| 1422 | 21 CFR 110.20(b)(4) | Floors, walls and ceilings |
| 1427 | 21 CFR 110.20(b)(5) | Safety lighting and glass |
| 1554 | 21 CFR 110.35(a) | Cleaning and sanitizing operations |
| 1562 | 21 CFR 110.35(d) | Failure to clean - general |
| 1571 | 21 CFR 110.35(d)(5) | Shown to be effective |
| 1597 | 21 CFR 110.37(b)(3) | As source of contamination |
| 1695 | 21 CFR 110.80(b)(2) | Manufacturing conditions |
| 2386 | 21 CFR 110.80(a)(1) | Storage |
| 3652 | 21 CFR 110.37(e)(1) | Suitable locations |
| 990 | 21 CFR 110.10(b)(3) | Not washed/sanitized when appropriate |