Advanced Cosmetic Research Laboratories
Form 483 issued April 27, 2022 · Chatsworth, California
- Inspection
- Apr 27, 2022
- Investigators
- Rachel C. Stanton· Rowena S. Nguyen· Sara H. Gabel
- Observations
- 6
- Pages
- 9
- FEI number
- 3003059934
In short: On April 27, 2022, FDA issued a Form 483 with 6 observations to Advanced Cosmetic Research Laboratories in Chatsworth, California (FEI 3003059934) after an inspection that ran Apr 27, 2022. The investigators were Rachel C. Stanton, Rowena S. Nguyen and Sara H. Gabel. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The suitability of all testing methods is not verified under actual conditions of use. Additionally, laboratory…
- 02
The responsibilities and procedures applicable to the quality control unit are not fully followed. There is…
- 03
Written procedures describing the handling of complaints do not include provisions for review by the quality…
- 04
The batch production and control records are deficient in that they are not checked for accuracy…
This inspection in context
Rachel C. Stanton
5 documents · 2022–2024
Cites 211.22(a) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmAdvanced Cosmetic Research Laboratories history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194(a)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advanced Cosmetic Research Laboratories?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls 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 Advanced Cosmetic Research Laboratories?
Rachel C. Stanton, Rowena S. Nguyen and Sara H. Gabel are named on this Form 483, for the inspection of Apr 27, 2022. Each investigator has a profile showing what they cite most.
When was Advanced Cosmetic Research Laboratories inspected by FDA?
The inspection ran Apr 27, 2022, and the Form 483 is dated April 27, 2022.
How do I get the full Form 483 for Advanced Cosmetic Research Laboratories?
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.