FDA Inspection 796955 — Protica, Inc.
The FDA completed an inspection of Protica, Inc. on August 27, 2012 in Whitehall, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 18 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 27, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Whitehall, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1471 | 21 CFR 113.83 | Scheduled processes not established |
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15580 | 21 CFR 111.155(c)(2) | Quality control - components; tests, examination results |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15808 | 21 CFR 111.570(a) | Records - product complaints: readily available |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 3082 | 21 CFR 114.89 | Process deviation |
| 3089 | 21 CFR 114.100(c) | Process deviations- identification and records |
| 4181 | 21 CFR 113.89 | Process deviation identification |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |
| 4477 | 21 CFR 108.25(d) | Reporting to FDA |
| 4515 | 21 CFR 108.35(c)(2) | Process filing |