Purolea Cosmetics Lab
Form 483 issued October 30, 2025 · Livonia, Michigan
- Inspection
- Oct 28 – Oct 30, 2025
- Investigator
- Melissa M. Steiger
- Observations
- 6
- Pages
- 8
- FEI number
- 3011669383
In short: On October 30, 2025, FDA issued a Form 483 with 6 observations to Purolea Cosmetics Lab in Livonia, Michigan (FEI 3011669383) after an inspection that ran Oct 28 – Oct 30, 2025. The investigator was Melissa M. Steiger. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Batch production and control records are not prepared for each batch of drug product produced and…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Melissa M. Steiger
7 documents · 2024–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Michigan.
The firmPurolea Cosmetics Lab history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Purolea Cosmetics Lab?
FDA listed 6 observations on this Form 483, mostly about production, laboratory controls and materials. The opening words of each observation are shown on this page.
Who inspected Purolea Cosmetics Lab?
Melissa M. Steiger is named on this Form 483, for the inspection of Oct 28 – Oct 30, 2025. Each investigator has a profile showing what they cite most.
When was Purolea Cosmetics Lab inspected by FDA?
The inspection ran Oct 28 – Oct 30, 2025, and the Form 483 is dated October 30, 2025.
How do I get the full Form 483 for Purolea Cosmetics Lab?
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.