West Coast Cosmetics Inc
Form 483 issued March 9, 2022 · Chatsworth, California
- Inspection
- Feb 23 – Mar 9, 2022
- Investigators
- Darren S. Brown· Dogbeda F. Mackenzie
- Observations
- 4
- Pages
- 6
- FEI number
- 3003352400
In short: On March 9, 2022, FDA issued a Form 483 with 4 observations to West Coast Cosmetics Inc in Chatsworth, California (FEI 3003352400) after an inspection that ran Feb 23 – Mar 9, 2022. The investigators were Darren S. Brown and Dogbeda F. Mackenzie. Most observations concern quality system and packaging & labeling.
At a glance
Quality system and packaging & labeling account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no quality…
- 02
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 03
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 04
Time limits are not established when appropriate for the completion of each production phase to assure…
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmWest Coast Cosmetics Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at West Coast Cosmetics Inc?
FDA listed 4 observations on this Form 483, mostly about quality system, packaging & labeling and production. The opening words of each observation are shown on this page.
Who inspected West Coast Cosmetics Inc?
Darren S. Brown and Dogbeda F. Mackenzie are named on this Form 483, for the inspection of Feb 23 – Mar 9, 2022. Each investigator has a profile showing what they cite most.
When was West Coast Cosmetics Inc inspected by FDA?
The inspection ran Feb 23 – Mar 9, 2022, and the Form 483 is dated March 9, 2022.
How do I get the full Form 483 for West Coast Cosmetics 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.