Overview
- 9 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.
9 Dec 2013
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Gayle S Lawson, Meena Bansal Gupta, Stephen J Koniers
9 Dec 2013
21 CFR 211.67(b)
Written procedures fail to include
Cited by Gayle S Lawson, Meena Bansal Gupta, Stephen J Koniers
9 Dec 2013
21 CFR 211.67(c)
Cleaning/maintenance records not kept
Cited by Gayle S Lawson, Meena Bansal Gupta, Stephen J Koniers
9 Dec 2013
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Gayle S Lawson, Meena Bansal Gupta, Stephen J Koniers
9 Dec 2013
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Gayle S Lawson, Meena Bansal Gupta, Stephen J Koniers
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 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(c) | 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 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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