FDA Inspection 961347 — BM Medical Management Services LLC.
The FDA completed an inspection of BM Medical Management Services LLC. on March 4, 2016 in Dallas, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 4, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12351 | 21 CFR 1271.190(d)(1) | Procedures for cleaning, sanitation |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12432 | 21 CFR 1271.265(e) | Documentation elements for activities |