Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
24 Feb 2022
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Erik W Koester, Terry Bridgewater
24 Feb 2022
21 CFR 211.67(b)(5)
Cleaning SOPs/equipment protection
Cited by Erik W Koester, Terry Bridgewater
24 Feb 2022
21 CFR 211.84(c)(4)
Top/Middle/Bottom container sampling
Cited by Erik W Koester, Terry Bridgewater
Inspected site
APAzurity Pharmaceuticals, Inc.Woburn, United States
Inspection team
TBTerry Bridgewater
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(c)(4) | 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 3 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