FDA Inspection 825509 — Castle Co-Packers LLC
The FDA completed an inspection of Castle Co-Packers LLC on April 11, 2013 in Latrobe, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 11, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Latrobe, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12732 | 21 CFR 120.10(a) | Corrective action - predetermined plan |
| 12747 | 21 CFR 120.8(b)(3) | HACCP plan - critical limits not listed or not adequate |
| 2391 | 21 CFR 110.80(a)(6) | Thawed appropriately |
| 9931 | 21 CFR 120.6(b) | Sanitation monitoring |
| 9932 | 21 CFR 120.6(a) | Sanitation SSOP - none or not implemented |
| 9939 | 21 CFR 120.7(c) | All hazards not considered |
| 9943 | 21 CFR 120.8(a) | HACCP plan - location and type of juice |
| 9946 | 21 CFR 120.11(b) | Validation - reviewer's qualifications |
| 9955 | 21 CFR 120.11(a)(1) | Verification activities - minimum |
| 9958 | 21 CFR 120.12(c) | Records - signed/dated |
| 9961 | 21 CFR 120.24(a) | Process controls - HACCP plan - 5 log reduction |