Overview
- 10 public-safe observations are available for this inspection.
- 9 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
1 Aug 2011
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Hala L Selby, Sam Pepe, Lance M De Souza
1 Aug 2011
21 CFR 211.67(b)(6)
Cleaning SOP/inspection
Cited by Hala L Selby, Sam Pepe, Lance M De Souza
1 Aug 2011
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Hala L Selby, Sam Pepe, Lance M De Souza
1 Aug 2011
21 CFR 211.100(a)
Approval and review of procedures
Cited by Hala L Selby, Sam Pepe, Lance M De Souza
1 Aug 2011
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Hala L Selby, Sam Pepe, Lance M De Souza
Inspected site
KIKVK-Tech, Inc.Newtown, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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