FDA Inspection 825989 — Beauty Manufacturing Solutions Corp.
The FDA completed an inspection of Beauty Manufacturing Solutions Corp. on Apr 4, 2013 in Coppell, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 4, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Coppell, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1393 | 21 CFR 211.103 | Yield calculations not verified by 2nd person |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4366 | 21 CFR 211.188(a) | Accurate reproduction included |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |