Cosmoceutical Research Center Inc.
Form 483 issued November 4, 2022 · PANORAMA CITY, California
- Inspection
- Oct 25 – Nov 4, 2022
- Investigator
- Claudia M. Perez-Kasmarski
- Observations
- 5
- Pages
- 5
- FEI number
- 3003490781
In short: On November 4, 2022, FDA issued a Form 483 with 5 observations to Cosmoceutical Research Center Inc. in PANORAMA CITY, California (FEI 3003490781) after an inspection that ran Oct 25 – Nov 4, 2022. The investigator was Claudia M. Perez-Kasmarski. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
The master production and control records for each batch size of drug product are not prepared…
- 04
The batch production and control records are deficient in that they are not an accurate reproduction…
This inspection in context
Claudia M. Perez-Kasmarski
11 documents · 2020–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmCosmoceutical Research Center Inc. 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 Cosmoceutical Research Center Inc.?
FDA listed 5 observations on this Form 483, mostly about production, quality system and materials. The opening words of each observation are shown on this page.
Who inspected Cosmoceutical Research Center Inc.?
Claudia M. Perez-Kasmarski is named on this Form 483, for the inspection of Oct 25 – Nov 4, 2022. Each investigator has a profile showing what they cite most.
When was Cosmoceutical Research Center Inc. inspected by FDA?
The inspection ran Oct 25 – Nov 4, 2022, and the Form 483 is dated November 4, 2022.
How do I get the full Form 483 for Cosmoceutical Research Center 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.