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.
8 Jul 2016
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Theressa B Smith, Julia D Cartwright
8 Jul 2016
21 CFR 606.100(c)
Record review prior to release
Cited by Theressa B Smith, Julia D Cartwright
8 Jul 2016
21 CFR 606.40(a)(1)
Provide space for examination
Cited by Theressa B Smith, Julia D Cartwright
8 Jul 2016
21 CFR 640.63(a)
Determination not made on day of collection
Cited by Theressa B Smith, Julia D Cartwright
Inspected site
BUBiomat USA, IncDenver, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.40(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.63(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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