Overview
- 20 public-safe observations are available for this inspection.
- 10 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.
14 Mar 2016
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Ko U Min, Gayle S Lawson, Sam Pepe
14 Mar 2016
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Ko U Min, Gayle S Lawson, Sam Pepe
14 Mar 2016
21 CFR 211.111
Establishment of time limitations
Cited by Ko U Min, Gayle S Lawson, Sam Pepe
14 Mar 2016
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Ko U Min, Gayle S Lawson, Sam Pepe
14 Mar 2016
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Ko U Min, Gayle S Lawson, Sam Pepe
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 | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 20 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