FDA Inspection 615160 — Renfrow Limited LLC
The FDA completed an inspection of Renfrow Limited LLC on Sep 29, 2009 in Ozark, MO. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 17 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 29, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Ozark, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |