FDA Inspection 609131 — Prodalim USA, Inc.
The FDA completed an inspection of Prodalim USA, Inc. on August 3, 2009 in Winter Garden, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 3, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Winter Garden, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1553 | 21 CFR 110.35(a) | Buildings/good repair |
| 9933 | 21 CFR 120.6(b) | GMP correction - timely |
| 9986 | 21 CFR 120.24(c) | Process controls - not exempt, single facility |