Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 6 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Acceptance of drug products
Cited by Joey V Quitania, Roger F Zabinski, Walden H Lee, Lillian S Wu, Andrew Le, Homero W Aguilar
Failing drug products not rejected
Cited by Joey V Quitania, Roger F Zabinski, Walden H Lee, Lillian S Wu, Andrew Le, Homero W Aguilar
Investigations of discrepancies, failures
Cited by Joey V Quitania, Roger F Zabinski, Walden H Lee, Lillian S Wu, Andrew Le, Homero W Aguilar
Procedures not in writing, fully followed
Cited by Joey V Quitania, Roger F Zabinski, Walden H Lee, Lillian S Wu, Andrew Le, Homero W Aguilar
Cleaning / Sanitizing / Maintenance
Cited by Joey V Quitania, Roger F Zabinski, Walden H Lee, Lillian S Wu, Andrew Le, Homero W Aguilar
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Source document
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 6 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