FDA Inspection 668320 — Portland Shellfish Co., Inc.
The FDA completed an inspection of Portland Shellfish Co., Inc. on June 15, 2010 in South Portland, ME. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 15, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- South Portland, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1406 | 21 CFR 110.10(b)(6) | Effective use of hair restraint |
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 16089 | FDCA 417(d)(1)(A) | Reportable food report - submission |
| 2361 | 21 CFR 110.80 | Testing |
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 6007 | 21 CFR 123.9(a) | Records entries - timing |
| 6008 | 21 CFR 123.8(a)(3) | Verification - record review - frequency |
| 6018 | 21 CFR 123.7(a) | Corrective action per predetermined plan |
| 905 | 21 CFR 123.6(b) | HACCP plan implementation |
| 908 | 21 CFR 123.6(d) | Signed and dated |
| 961 | 21 CFR 123.6(c)(3) | Critical limits |
| 963 | 21 CFR 123.6(c)(5) | Corrective action plan |