TAKA USA, INC. dba Cosmetic Innovations
Form 483 issued February 7, 2023 · Coppell, Texas
- Inspection
- Jan 17 – Feb 7, 2023
- Investigators
- Michelle A. Krayer· Shelby N. Turner
- Observations
- 9
- Pages
- 9
- FEI number
- 3013239969
In short: On February 7, 2023, FDA issued a Form 483 with 9 observations to TAKA USA, INC. dba Cosmetic Innovations in Coppell, Texas (FEI 3013239969) after an inspection that ran Jan 17 – Feb 7, 2023. The investigators were Michelle A. Krayer and Shelby N. Turner. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
Batch production and control records do not include complete information relating to the production and…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
Michelle A. Krayer
11 documents · 2019–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Texas.
The firmTAKA USA, INC. dba Cosmetic Innovations history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at TAKA USA, INC. dba Cosmetic Innovations?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected TAKA USA, INC. dba Cosmetic Innovations?
Michelle A. Krayer and Shelby N. Turner are named on this Form 483, for the inspection of Jan 17 – Feb 7, 2023. Each investigator has a profile showing what they cite most.
When was TAKA USA, INC. dba Cosmetic Innovations inspected by FDA?
The inspection ran Jan 17 – Feb 7, 2023, and the Form 483 is dated February 7, 2023.
How do I get the full Form 483 for TAKA USA, INC. dba Cosmetic Innovations?
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