TAKA USA, INC. dba Cosmetic Innovations

Form 483 issued June 6, 2019 · Carrollton, Texas

Inspection: Jun 3 – Jun 6, 2019
Investigator: Patty P. Kaewussdangkul
Observations: 7
Pages: 5
FEI number: 3013239969

In short: On June 6, 2019, FDA issued a Form 483 with 7 observations to TAKA USA, INC. dba Cosmetic Innovations in Carrollton, Texas (FEI 3013239969) after an inspection that ran Jun 3 – Jun 6, 2019. The investigator was Patty P. Kaewussdangkul. Most observations concern laboratory controls and production.

At a glance

Observations span 4 systems, led by laboratory controls.

Laboratory controls2

Production2

Quality system1

Facilities & equipment1

Other1

What FDA observed

Preview: the opening words of each observation

01
21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit…
02
21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
03
21 CFR 211.166(a)
There is no written testing program designed to assess the stability…
04
21 CFR 211.110(a)
Control procedures are not established which of those manufacturing processes that may be responsible for causing…

3 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Patty P. Kaewussdangkul

54 documents · 2006–2026

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.

The firm

TAKA 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 483s

Other sites cited under 211.22(d)

See how FDA wrote the same problem up elsewhere.

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Form 483 from this inspectionJun 6, 2019$99

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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 laboratory controls, production and quality system. The opening words of each observation are shown on this page.

Who inspected TAKA USA, INC. dba Cosmetic Innovations?

Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Jun 3 – Jun 6, 2019. Each investigator has a profile showing what they cite most.

When was TAKA USA, INC. dba Cosmetic Innovations inspected by FDA?

The inspection ran Jun 3 – Jun 6, 2019, and the Form 483 is dated June 6, 2019.

How do I get the full Form 483 for TAKA USA, INC. dba Cosmetic Innovations?

Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.