FDA Inspection 859564 — Dermamedics, L.L.C.
The FDA completed an inspection of Dermamedics, L.L.C. on December 19, 2013 in Oklahoma City, OK. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 19, 2013
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Oklahoma City, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |