FDA Inspection 698012 — Four Seas, Inc.
The FDA completed an inspection of Four Seas, Inc. on November 12, 2010 in Boston, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 12, 2010
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Boston, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 1525 | 21 CFR 123.11(c) | Sanitation Records |
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 6008 | 21 CFR 123.8(a)(3) | Verification - record review - frequency |
| 6019 | 21 CFR 123.8(a)(2) | Ongoing verification - complaints, calibration records |
| 6020 | 21 CFR 123.9(a) | Records - content |
| 905 | 21 CFR 123.6(b) | HACCP plan implementation |
| 933 | 21 CFR 123.8(a)(2)(ii) | Calibration - adequacy |
| 963 | 21 CFR 123.6(c)(5) | Corrective action plan |