TAKA USA, INC. dba Cosmetic Innovations
FDA inspection history across 2 sites, 2019 to 2023
- 4
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2019: two Form 483s; 2020: one close-out letter; 2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–23Four Form 483s and one close-out letter, at Coppell, Texas and Carrollton, Texas.
- 2023The longest 483 on file: 9 observations over 9 pages at Coppell, Texas.
Cited most
Across all TAKA USA, INC. dba Cosmetic Innovations observations on file
- 21 CFR 211.165(a)Testing and release for distribution5
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products4
- 21 CFR 211.188Batch production and control records4
- 21 CFR 211.22(d)Responsibilities of quality control unit4
- 21 CFR 211.67(b)Equipment cleaning and maintenance4
The complete TAKA USA, INC. dba Cosmetic Innovations file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Coppell, Texas
Three Form 483s · 2019 to 2023 · 23 observations
Latest: Form 483, Feb 7, 2023 →Carrollton, Texas
One close-out letter and one Form 483 · 2019 to 2020 · 7 observations
Latest: Close-out, Jul 29, 2020 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-02-07 | 483 Form 483 | Coppell, Texas | 9 | $99 |
| 2021-09-27 | 483 Form 483 | Coppell, Texas | 7 | $99 |
| 2020-07-29 | Close-out Close-out letter | Carrollton, Texas | — | $99 |
| 2019-06-06 | 483 Form 483 | Coppell, Texas | 7 | $99 |
| 2019-06-06 | 483 Form 483 | Carrollton, Texas | 7 | $99 |
Investigators on these documents
Michelle A. Krayer (2)Ariel Cruz Figueroa (1)Patty P. Kaewussdangkul (1)Shelby N. Turner (1)
FEI number 3013239969 · most recent document Feb 7, 2023
About TAKA USA, INC. dba Cosmetic Innovations
How many FDA Form 483s has TAKA USA, INC. dba Cosmetic Innovations received?
FDA Intel has 4 Form 483s on file for TAKA USA, INC. dba Cosmetic Innovations; the most recent is dated Feb 7, 2023.
When was TAKA USA, INC. dba Cosmetic Innovations last inspected by FDA?
The most recent FDA inspection document on file for TAKA USA, INC. dba Cosmetic Innovations is a Form 483 dated Feb 7, 2023, for the site in Coppell, Texas.
What did FDA cite at TAKA USA, INC. dba Cosmetic Innovations?
The regulations cited most in the observations on file for TAKA USA, INC. dba Cosmetic Innovations are 21 CFR 211.165(a) (Testing and release for distribution), 5 times; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 4 times; 21 CFR 211.188 (Batch production and control records), 4 times.