Cosmetic Enterprises Ltd.
Form 483 issued June 11, 2021 · Pacoima, California
- Inspection
- Jun 7 – Jun 11, 2021
- Investigator
- Dogbeda F. Mackenzie
- Observations
- 8
- Pages
- 5
- FEI number
- 2025292
In short: On June 11, 2021, FDA issued a Form 483 with 8 observations to Cosmetic Enterprises Ltd. in Pacoima, California (FEI 2025292) after an inspection that ran Jun 7 – Jun 11, 2021. The investigator was Dogbeda F. Mackenzie. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with…
- 03
Investigations of a failure of a batch or any of its components to meet any of…
- 04
The responsibilities and procedures applicable to the quality control unit…
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 Enterprises Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cosmetic Enterprises Ltd.?
FDA listed 8 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Cosmetic Enterprises Ltd.?
Dogbeda F. Mackenzie is named on this Form 483, for the inspection of Jun 7 – Jun 11, 2021. Each investigator has a profile showing what they cite most.
When was Cosmetic Enterprises Ltd. inspected by FDA?
The inspection ran Jun 7 – Jun 11, 2021, and the Form 483 is dated June 11, 2021.
How do I get the full Form 483 for Cosmetic Enterprises Ltd.?
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.