FDA Inspection 643456 — Protica, Inc.
The FDA completed an inspection of Protica, Inc. on January 13, 2010 in Whitehall, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 13, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Whitehall, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15572 | 21 CFR 111.153 | Written procedures - labels |
| 15580 | 21 CFR 111.155(c)(2) | Quality control - components; tests, examination results |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 3071 | 21 CFR 114.80(a)(1) | Scheduled process |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |