Cosmetic Group USA, Inc.
Form 483 issued April 14, 2021 · Pacoima, California
- Inspection
- Apr 5 – Apr 14, 2021
- Investigators
- Dogbeda F. Mackenzie· Kouros Kangarli
- Observations
- 4
- Pages
- 5
- FEI number
- 3003800883
In short: On April 14, 2021, FDA issued a Form 483 with 4 observations to Cosmetic Group USA, Inc. in Pacoima, California (FEI 3003800883) after an inspection that ran Apr 5 – Apr 14, 2021. The investigators were Dogbeda F. Mackenzie and Kouros Kangarli. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Employees engaged in the processing of a drug product lack the training and experience required to…
- 03
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
- 04
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix…
This inspection in context
Dogbeda F. Mackenzie
14 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmCosmetic Group USA, 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 Cosmetic Group USA, Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Cosmetic Group USA, Inc.?
Dogbeda F. Mackenzie and Kouros Kangarli are named on this Form 483, for the inspection of Apr 5 – Apr 14, 2021. Each investigator has a profile showing what they cite most.
When was Cosmetic Group USA, Inc. inspected by FDA?
The inspection ran Apr 5 – Apr 14, 2021, and the Form 483 is dated April 14, 2021.
How do I get the full Form 483 for Cosmetic Group USA, 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.