FDA Inspection 807450 — American Aesthetics Medical Supply, Inc.
The FDA completed an inspection of American Aesthetics Medical Supply, Inc. on November 13, 2012 in Dallas, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 13, 2012
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |