COSMETIC LABORATORY INC
Form 483 issued August 3, 2022 · Downey, California
- Inspection
- Jul 26 – Aug 3, 2022
- Investigators
- Alan L. Truong· Youkeun Kim
- Observations
- 5
- Pages
- 6
- FEI number
- 3011959287
In short: On August 3, 2022, FDA issued a Form 483 with 5 observations to COSMETIC LABORATORY INC in Downey, California (FEI 3011959287) after an inspection that ran Jul 26 – Aug 3, 2022. The investigators were Alan L. Truong and Youkeun Kim. Most observations concern quality system and materials.
At a glance
Quality system and materials account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Alan L. Truong
16 documents · 2019–2025
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in California.
The firmCOSMETIC LABORATORY INC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at COSMETIC LABORATORY INC?
FDA listed 5 observations on this Form 483, mostly about quality system, materials and production. The opening words of each observation are shown on this page.
Who inspected COSMETIC LABORATORY INC?
Alan L. Truong and Youkeun Kim are named on this Form 483, for the inspection of Jul 26 – Aug 3, 2022. Each investigator has a profile showing what they cite most.
When was COSMETIC LABORATORY INC inspected by FDA?
The inspection ran Jul 26 – Aug 3, 2022, and the Form 483 is dated August 3, 2022.
How do I get the full Form 483 for COSMETIC LABORATORY 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.