TAKA USA, INC. dba Cosmetic Innovations
Form 483 issued September 27, 2021 · Coppell, Texas
- Inspection
- Sep 20 – Sep 27, 2021
- Investigators
- Ariel Cruz Figueroa· Michelle A. Krayer
- Observations
- 7
- Pages
- 5
- FEI number
- 3013239969
In short: On September 27, 2021, FDA issued a Form 483 with 7 observations to TAKA USA, INC. dba Cosmetic Innovations in Coppell, Texas (FEI 3013239969) after an inspection that ran Sep 20 – Sep 27, 2021. The investigators were Ariel Cruz Figueroa and Michelle A. Krayer. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Employees are not given training in the particular operations they perform as part of their function…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Ariel Cruz Figueroa
16 documents · 2015–2023
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Puerto Rico.
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 211.25(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 7 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected TAKA USA, INC. dba Cosmetic Innovations?
Ariel Cruz Figueroa and Michelle A. Krayer are named on this Form 483, for the inspection of Sep 20 – Sep 27, 2021. Each investigator has a profile showing what they cite most.
When was TAKA USA, INC. dba Cosmetic Innovations inspected by FDA?
The inspection ran Sep 20 – Sep 27, 2021, and the Form 483 is dated September 27, 2021.
How do I get the full Form 483 for TAKA USA, INC. dba Cosmetic Innovations?
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