Overview
- 22 public-safe observations are available for this inspection.
- 11 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.
1 Apr 2016
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Jai P Singh, Walden H Lee, Arie Menachem, Lance A Finnical
1 Apr 2016
21 CFR 211.160(b)(2)
In-process samples representative, identified properly
Cited by Jai P Singh, Walden H Lee, Arie Menachem, Lance A Finnical
1 Apr 2016
21 CFR 211.165(e)
Test methods
Cited by Jai P Singh, Walden H Lee, Arie Menachem, Lance A Finnical
1 Apr 2016
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Jai P Singh, Walden H Lee, Arie Menachem, Lance A Finnical
1 Apr 2016
21 CFR 211.182
Written records kept in individual logs
Cited by Jai P Singh, Walden H Lee, Arie Menachem, Lance A Finnical
Inspected site
PCPureTek CorporationSan Fernando, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 22 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