FDA Inspection 1110699 — PRL Inc
The FDA completed an inspection of PRL Inc on November 22, 2019 in Lobelville, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 22, 2019
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lobelville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15544 | 21 CFR 111.260(d) | Batch record - component; unique identifier |
| 15559 | 21 CFR 111.260(k)(1) | Batch record - identifier; labels |
| 15598 | 21 CFR 111.160(d)(1) | Packaging - identify |
| 15599 | 21 CFR 111.160(d)(1) | Labels - identify |
| 15746 | 21 CFR 111.210(h)(1) | Instructions; specifications; quality |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 16038 | 21 CFR 111.605(b) | Records - original, true copies |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |