FDA Inspection 723920 — PROLAC, INC.
The FDA completed an inspection of PROLAC, INC. on May 10, 2011 in Bayamon, PR. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- May 10, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Bayamon, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 1552 | 21 CFR 110.35(a) | Buildings/sanitary |
| 1556 | 21 CFR 110.35(b)(2) | Storage requirements |
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 1570 | 21 CFR 110.35(d)(5) | Safe and adequate for use |
| 1571 | 21 CFR 110.35(d)(5) | Shown to be effective |
| 1581 | 21 CFR 110.37(e) | Running water at suitable temperature |
| 1597 | 21 CFR 110.37(b)(3) | As source of contamination |
| 1689 | 21 CFR 110.80 | Reasonable precautions |
| 1695 | 21 CFR 110.80(b)(2) | Manufacturing conditions |
| 3647 | 21 CFR 110.10(c) | Training of handlers and supervisors |
| 3661 | 21 CFR 110.37(e)(5) | Signs |
| 3712 | 21 CFR 110.93 | Storage/transportation of finished goods (deterioration) |