FDA Inspection 747167 — Portland Shellfish Co., Inc.
The FDA completed an inspection of Portland Shellfish Co., Inc. on September 26, 2011 in South Portland, ME. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 26, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- South Portland, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 10005 | n/a | Procedural requirements |
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 6001 | 21 CFR 123.11(b) | Sanitation monitoring documentation |
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 6010 | 21 CFR 123.8(a)(3)(i) | Monitoring record review adequacy |
| 6014 | 21 CFR 123.6(c)(2) | Monitoring - none |
| 6018 | 21 CFR 123.7(a) | Corrective action per predetermined plan |
| 6020 | 21 CFR 123.9(a) | Records - content |
| 959 | 21 CFR 123.6(c)(1) | Food safety hazards |
| 960 | 21 CFR 123.6(c)(2) | Critical control points |
| 963 | 21 CFR 123.6(c)(5) | Corrective action plan |