FDA Inspection 1069937 — PRL Inc
The FDA completed an inspection of PRL Inc on October 26, 2018 in Lobelville, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 26, 2018
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lobelville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15432 | 21 CFR 111.15(e)(2) | Water supply - may be component - suitability |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15560 | 21 CFR 111.260(k)(2) | Batch record - label |
| 15749 | 21 CFR 111.210(e) | Master manufacturing record - intentional overage |
| 15779 | 21 CFR 111.415(a) | Clean, sanitize - filling, packaging equipment |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |