Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-02-07.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Jan 2023 – 7 Feb 2023 | Human Drugs | 483 | On file |
| 20 Sep 2021 – 27 Sep 2021 | Human Drugs | 483 | On file |
| 3 Jun 2019 – 6 Jun 2019 | Human Drugs | WL | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Feb 2023
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Michelle A Krayer, Shelby N Turner
7 Feb 2023
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Michelle A Krayer, Shelby N Turner
7 Feb 2023
21 CFR 211.165(a)
Testing and release for distribution
Cited by Michelle A Krayer, Shelby N Turner
7 Feb 2023
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Michelle A Krayer, Shelby N Turner
Investigators
FDA investigators tied to this site in the record.
Michelle A Krayer2 insp.
Shelby N Turner1 insp.
Ariel Cruz Figueroa1 insp.
Patty P Kaewussdangkul1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Taka USA Inc. dba Cosmetic Innovations' 3 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat