FDA Inspection 856574 — Protica, Inc.
The FDA completed an inspection of Protica, Inc. on November 6, 2013 in Whitehall, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 6, 2013
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Whitehall, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |
| 4475 | 21 CFR 108.25(c)(3)(i) | Process adherence |