Overview
- 60 public-safe observations are available for this inspection.
- 15 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
8 Nov 2019
21 CFR 1010.3(a)(2)(ii)
Manufacture date abbreviated or unapproved date coding
Cited by James R Montero
8 Nov 2019
21 CFR 1010.3(a)(2)(ii)
Manufacture date abbreviated or unapproved date coding
Cited by James R Montero
Inspected site
KIKBD Inc DBA Sperti SunlampNorth Las Vegas, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 1010.2(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1010.3(a)(2)(ii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1040.20(d)(1)(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1040.20(d)(2)(iii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 3x |
Source document
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Form 483 source document
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Full 483 report
Get the verbatim text of all 60 observations
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- 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