G.S. COSMECEUTICAL USA, INC.
Form 483 issued December 3, 2015 · Livermore, California
- Inspection
- Feb 23 – Dec 3, 2015
- Observations
- 5
- Pages
- 5
- FEI number
- 3002749414
In short: On December 3, 2015, FDA issued a Form 483 with 5 observations to G.S. COSMECEUTICAL USA, INC. in Livermore, California (FEI 3002749414) after an inspection that ran Feb 23 – Dec 3, 2015. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Questions about this 483
What did FDA find at G.S. COSMECEUTICAL USA, INC.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The opening words of each observation are shown on this page.
When was G.S. COSMECEUTICAL USA, INC. inspected by FDA?
The inspection ran Feb 23 – Dec 3, 2015, and the Form 483 is dated December 3, 2015.
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.