FDA Intel

G.S. COSMECEUTICAL USA, INC.

Form 483 issued August 14, 2019 · Livermore, California

Observations
6
Pages
4
FEI number
3002749414

In short: On August 14, 2019, FDA issued a Form 483 with 6 observations to G.S. COSMECEUTICAL USA, INC. in Livermore, California (FEI 3002749414). Most observations concern quality system and production.

At a glance

Quality system and production account for 4 of 6 observations.

Quality system2
Production2
Facilities & equipment2

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 211.25(a)

    GMP training is not conducted on a continuing basis to assure that employees remain familiar with…

  3. 03
    21 CFR 211.110(a)

    Control procedures are not established which validate the performance of those manufacturing processes that may be…

  4. 04
    21 CFR 211.100(a)

    There are no written procedures for production and process controls designed to assure that the drug…

2 more observations

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

Get the full 483

This inspection in context

The firm

G.S. COSMECEUTICAL USA, INC. history

All 2 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 G.S. COSMECEUTICAL USA, INC.?

FDA listed 6 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.

When was G.S. COSMECEUTICAL USA, INC. inspected by FDA?

This Form 483 is dated August 14, 2019.

How do I get the full Form 483 for G.S. COSMECEUTICAL USA, INC.?

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.

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