FDA Inspection 548692 — Lakewood Organics LLC
The FDA completed an inspection of Lakewood Organics LLC on November 21, 2008 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 21, 2008
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1172 | 21 CFR 110.40(e) | Lack of thermometer |
| 12742 | 21 CFR 120.8(a) | HACCP plan not implemented |
| 12746 | 21 CFR 120.8(b)(2) | HACCP plan - critical control points not listed |
| 12747 | 21 CFR 120.8(b)(3) | HACCP plan - critical limits not listed or not adequate |
| 15302 | 21 CFR 120.11(a)(2) | Calibration, testing - no records |
| 15305 | 21 CFR 120.14(a)(2) | Importer - implementation of affirmative steps |
| 3712 | 21 CFR 110.93 | Storage/transportation of finished goods (deterioration) |
| 9919 | 21 CFR 120.10(a) | Corrective action - predetermined plan inadequate |
| 9926 | 21 CFR 120.14(a) | Importer - written procedures |
| 9930 | 21 CFR 120.6(c) | SSOP records |
| 9931 | 21 CFR 120.6(b) | Sanitation monitoring |
| 9935 | 21 CFR 120.7(a) | No hazard analysis |
| 9955 | 21 CFR 120.11(a)(1) | Verification activities - minimum |