Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
4 Apr 2022
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Erik W Koester, Jonah S Ufferfilge
4 Apr 2022
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Erik W Koester, Jonah S Ufferfilge
4 Apr 2022
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Erik W Koester, Jonah S Ufferfilge
4 Apr 2022
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Erik W Koester, Jonah S Ufferfilge
Inspected site
BMBrookfield Medical/Surgical Supplies, Inc.Brookfield, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 5 observations
The source PDF, 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