Advanced Cosmetic Research Laboratories
Form 483 issued July 24, 2023 · Chatsworth, California
- Inspection
- Jul 17 – Jul 24, 2023
- Investigators
- Khoa Nathan V. Tran· Rowena S. Nguyen
- Observations
- 9
- Pages
- 9
- FEI number
- 3003059934
In short: On July 24, 2023, FDA issued a Form 483 with 9 observations to Advanced Cosmetic Research Laboratories in Chatsworth, California (FEI 3003059934) after an inspection that ran Jul 17 – Jul 24, 2023. The investigators were Khoa Nathan V. Tran and Rowena S. Nguyen. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 6 of 9 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Individuals responsible for supervising the manufacture, processing, packing and holding of a drug product lack the…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
Drug product production and control records, are not reviewed and approved by the quality control unit…
- 04
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Khoa Nathan V. Tran
21 documents · 2021–2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advanced Cosmetic Research Laboratories?
FDA listed 9 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Advanced Cosmetic Research Laboratories?
Khoa Nathan V. Tran and Rowena S. Nguyen are named on this Form 483, for the inspection of Jul 17 – Jul 24, 2023. Each investigator has a profile showing what they cite most.
When was Advanced Cosmetic Research Laboratories inspected by FDA?
The inspection ran Jul 17 – Jul 24, 2023, and the Form 483 is dated July 24, 2023.
How do I get the full Form 483 for Advanced Cosmetic Research Laboratories?
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