Purolea Cosmetics Lab
FDA inspection history in Livonia, Michigan, 2025 to 2026
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2025: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2025–26One Form 483 and one warning letter, at Livonia, Michigan.
Cited most
Across all Purolea Cosmetics Lab observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Purolea Cosmetics Lab file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Livonia, Michigan
One warning letter and one Form 483 · 2025 to 2026 · 6 observations
Latest: Warning letter, Apr 2, 2026 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-04-02 | Warning letter Warning letter | Livonia, Michigan | — | $99 |
| 2025-10-30 | 483 Form 483 | Livonia, Michigan | 6 | $99 |
Investigators on these documents
FEI number 3011669383 · most recent document Apr 2, 2026
About Purolea Cosmetics Lab
How many FDA Form 483s has Purolea Cosmetics Lab received?
FDA Intel has 1 Form 483 on file for Purolea Cosmetics Lab; the most recent is dated Oct 30, 2025.
When was Purolea Cosmetics Lab last inspected by FDA?
The most recent FDA inspection document on file for Purolea Cosmetics Lab is a Form 483 dated Oct 30, 2025, for the site in Livonia, Michigan.
What did FDA cite at Purolea Cosmetics Lab?
The regulations cited most in the observations on file for Purolea Cosmetics Lab are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time.
Has Purolea Cosmetics Lab received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Purolea Cosmetics Lab; the most recent is dated Apr 2, 2026.