Overview
- 7 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
2 Nov 2017
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Linda Thai, Walden H Lee, Jennifer M Gogley, Jolanna A Norton
2 Nov 2017
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Linda Thai, Walden H Lee, Jennifer M Gogley, Jolanna A Norton
2 Nov 2017
21 CFR 211.165(e)
Test methods
Cited by Linda Thai, Walden H Lee, Jennifer M Gogley, Jolanna A Norton
2 Nov 2017
21 CFR 211.166(a)(4)
Testing in same container - closure system
Cited by Linda Thai, Walden H Lee, Jennifer M Gogley, Jolanna A Norton
2 Nov 2017
21 CFR 211.188(b)(7)
Actual yield, % of theoretical yield
Cited by Linda Thai, Walden H Lee, Jennifer M Gogley, Jolanna A Norton
Inspected site
NANitto Avecia Pharma Services, Inc.Irvine, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 observations
The full inspection record, as Atlas holds it, 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