FDA Inspection 922588 — E R K Distributors LLC.
The FDA completed an inspection of E R K Distributors LLC. on April 8, 2015 in Rochester Hills, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 8, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Rochester Hills, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 6001 | 21 CFR 123.11(b) | Sanitation monitoring documentation |
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 6018 | 21 CFR 123.7(a) | Corrective action per predetermined plan |
| 905 | 21 CFR 123.6(b) | HACCP plan implementation |
| 933 | 21 CFR 123.8(a)(2)(ii) | Calibration - adequacy |
| 960 | 21 CFR 123.6(c)(2) | Critical control points |
| 963 | 21 CFR 123.6(c)(5) | Corrective action plan |