Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
11 Jun 2021
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Junho Pak, Michele Gottshall, Karen A Briggs
11 Jun 2021
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Junho Pak, Michele Gottshall, Karen A Briggs
11 Jun 2021
21 CFR 211.22(c)
Approve or reject procedures or specs
Cited by Junho Pak, Michele Gottshall, Karen A Briggs
11 Jun 2021
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Junho Pak, Michele Gottshall, Karen A Briggs
11 Jun 2021
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Junho Pak, Michele Gottshall, Karen A Briggs
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 | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 8 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