Cosmetic Manufacturers (Aust) Pty Ltd.
Form 483 issued April 8, 2025
- Inspection
- Mar 31 – Apr 8, 2025
- Investigator
- Brandy N. Lepage
- Observations
- 4
- Pages
- 5
- FEI number
- 3007187387
In short: On April 8, 2025, FDA issued a Form 483 with 4 observations to Cosmetic Manufacturers (Aust) Pty Ltd. (FEI 3007187387) after an inspection that ran Mar 31 – Apr 8, 2025. The investigator was Brandy N. Lepage. Most observations concern production and facilities & equipment.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
There is a failure to thoroughly review the failure of a batch or any of its…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmCosmetic Manufacturers (Aust) Pty Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cosmetic Manufacturers (Aust) Pty Ltd.?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Cosmetic Manufacturers (Aust) Pty Ltd.?
Brandy N. Lepage is named on this Form 483, for the inspection of Mar 31 – Apr 8, 2025. Each investigator has a profile showing what they cite most.
When was Cosmetic Manufacturers (Aust) Pty Ltd. inspected by FDA?
The inspection ran Mar 31 – Apr 8, 2025, and the Form 483 is dated April 8, 2025.
How do I get the full Form 483 for Cosmetic Manufacturers (Aust) Pty 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.