Advanced Cosmetic Research Laboratories
Form 483 issued June 7, 2021 · Chatsworth, California
- Inspection
- Jun 2 – Jun 7, 2021
- Investigators
- Crystal Monroy· Taichun Qin
- Observations
- 5
- Pages
- 5
- FEI number
- 3003059934
In short: On June 7, 2021, FDA issued a Form 483 with 5 observations to Advanced Cosmetic Research Laboratories in Chatsworth, California (FEI 3003059934) after an inspection that ran Jun 2 – Jun 7, 2021. The investigators were Crystal Monroy and Taichun Qin. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 02
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
- 03
Written procedures are not drafted, reviewed and approved by…
- 04
Employees are not given training in the particular operations they perform as…
This inspection in context
Crystal Monroy
15 documents · 2014–2026
Cites 211.192 (production record review) 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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advanced Cosmetic Research Laboratories?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Advanced Cosmetic Research Laboratories?
Crystal Monroy and Taichun Qin are named on this Form 483, for the inspection of Jun 2 – Jun 7, 2021. Each investigator has a profile showing what they cite most.
When was Advanced Cosmetic Research Laboratories inspected by FDA?
The inspection ran Jun 2 – Jun 7, 2021, and the Form 483 is dated June 7, 2021.
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.