Overview
- 3 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
4 Mar 2016
21 CFR 1271.260(e)
Storage temperatures recorded, maintained
Cited by Elmina E Akwo, Yaw O Osei, Elmina E Mboh
4 Mar 2016
21 CFR 1271.265(e)
Documentation elements for activities
Cited by Elmina E Akwo, Yaw O Osei, Elmina E Mboh
4 Mar 2016
21 CFR 1271.190(d)(1)
Procedures for cleaning, sanitation
Cited by Elmina E Akwo, Yaw O Osei, Elmina E Mboh
Inspected site
BMBM Medical Management Services LLC.Dallas, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.190(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.260(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.265(e) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere