FDA Inspection 770437 — Plenus Group Inc.
The FDA completed an inspection of Plenus Group Inc. on March 2, 2012 in Lowell, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 2, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Lowell, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 6020 | 21 CFR 123.9(a) | Records - content |
| 933 | 21 CFR 123.8(a)(2)(ii) | Calibration - adequacy |
| 960 | 21 CFR 123.6(c)(2) | Critical control points |
| 961 | 21 CFR 123.6(c)(3) | Critical limits |