FDA Inspection 612996 — PROLAC, INC.
The FDA completed an inspection of PROLAC, INC. on Sep 21, 2009 in Bayamon, PR. 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). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 21, 2009
- Fiscal Year
- 2009
- 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 |
| 1184 | 21 CFR 110.35(e) | Storage of cleaned portable equipment (S) |
| 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 |
| 1597 | 21 CFR 110.37(b)(3) | As source of contamination |
| 1602 | 21 CFR 110.37(a) | Suitable temp. and pressure |
| 1689 | 21 CFR 110.80 | Reasonable precautions |
| 2388 | 21 CFR 110.80(a)(5) | Holding in bulk or suitable containers |
| 3712 | 21 CFR 110.93 | Storage/transportation of finished goods (deterioration) |