Overview
- 6 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 5 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
31 Aug 2009
21 CFR 211.67(c)
Cleaning/maintenance records not kept
Cited by Cynthia A Palmer, Vlada Matusovsky, Julianne C Mccullough, Lisa M Bellows, Linda M Hoover
31 Aug 2009
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Cynthia A Palmer, Vlada Matusovsky, Julianne C Mccullough, Lisa M Bellows, Linda M Hoover
31 Aug 2009
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Cynthia A Palmer, Vlada Matusovsky, Julianne C Mccullough, Lisa M Bellows, Linda M Hoover
31 Aug 2009
21 CFR 211.165(e)
Test methods
Cited by Cynthia A Palmer, Vlada Matusovsky, Julianne C Mccullough, Lisa M Bellows, Linda M Hoover
31 Aug 2009
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Cynthia A Palmer, Vlada Matusovsky, Julianne C Mccullough, Lisa M Bellows, Linda M Hoover
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 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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