Goodier Cosmetics
Form 483 issued August 23, 2022 · Dallas, Texas
- Inspection
- Aug 16 – Aug 23, 2022
- Investigators
- Charles D. Brown· Shanna N. Purdy
- Observations
- 2
- Pages
- 4
- FEI number
- 1611064
In short: On August 23, 2022, FDA issued a Form 483 with 2 observations to Goodier Cosmetics in Dallas, Texas (FEI 1611064) after an inspection that ran Aug 16 – Aug 23, 2022. The investigators were Charles D. Brown and Shanna N. Purdy. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.113(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
This inspection in context
Charles D. Brown
3 documents · 2007–2022
Cites 110.80 (processes and controls) more than any other section. Most of their documents are for sites in New Mexico.
The firmGoodier Cosmetics history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Goodier Cosmetics?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Goodier Cosmetics?
Charles D. Brown and Shanna N. Purdy are named on this Form 483, for the inspection of Aug 16 – Aug 23, 2022. Each investigator has a profile showing what they cite most.
When was Goodier Cosmetics inspected by FDA?
The inspection ran Aug 16 – Aug 23, 2022, and the Form 483 is dated August 23, 2022.
How do I get the full Form 483 for Goodier Cosmetics?
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.