Gabriel Cosmetics Inc
Form 483 issued June 16, 2016 · Redmond, Washington
- Inspection
- Jun 9 – Jun 16, 2016
- Investigators
- Avery J. Dennis· Nancy E. Byerly
- Observations
- 5
- Pages
- 3
- FEI number
- 3003384668
In short: On June 16, 2016, FDA issued a Form 483 with 5 observations to Gabriel Cosmetics Inc in Redmond, Washington (FEI 3003384668) after an inspection that ran Jun 9 – Jun 16, 2016. The investigators were Avery J. Dennis and Nancy E. Byerly. Most observations concern quality system and packaging & labeling.
At a glance
Quality system and packaging & labeling account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Written procedures for the warehousing of drug products do not include quarantine of drug products before…
- 03
Strict control is not exercised over labeling issued for use in…
- 04
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
This inspection in context
Avery J. Dennis
1 document · 2016
Cites 211.125(a) (labeling issuance) more than any other section. Most of their documents are for sites in Washington.
The firmGabriel Cosmetics Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Gabriel Cosmetics Inc?
FDA listed 5 observations on this Form 483, mostly about quality system, packaging & labeling and materials. The opening words of each observation are shown on this page.
Who inspected Gabriel Cosmetics Inc?
Avery J. Dennis and Nancy E. Byerly are named on this Form 483, for the inspection of Jun 9 – Jun 16, 2016. Each investigator has a profile showing what they cite most.
When was Gabriel Cosmetics Inc inspected by FDA?
The inspection ran Jun 9 – Jun 16, 2016, and the Form 483 is dated June 16, 2016.
How do I get the full Form 483 for Gabriel Cosmetics 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.