FDA Intel

TAKA USA, INC. dba Cosmetic Innovations

Form 483 issued June 6, 2019 · Coppell, Texas

Inspection
Jun 3 – Jun 6, 2019
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 Coppell, Texas (FEI 3013239969) after an inspection that ran Jun 3 – Jun 6, 2019. 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
  1. 01
    21 CFR 211.22(d)

    The responsibilities and procedures applicable to the quality control unit…

  2. 02
    21 CFR 211.165(a)

    Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…

  3. 03
    21 CFR 211.166(a)

    There is no written testing program designed to assess the stability…

  4. 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.

Get the full 483

This inspection in context

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.

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.

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?

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