Sombra Cosmetics Inc.
FDA inspection history across 2 sites, 2024
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One warning letter and one Form 483, at Albuquerque, New Mexico and ALBUQUERQUE, New Mexico.
Cited most
Across all Sombra Cosmetics observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.165(e)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.180(e)General requirements1
The complete Sombra Cosmetics 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
Albuquerque, New Mexico
One warning letter · 2024
Latest: Warning letter, Dec 18, 2024 →ALBUQUERQUE, New Mexico
One Form 483 · 2024 · 8 observations
Latest: Form 483, Jul 26, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-18 | Warning letter Warning letter | Albuquerque, New Mexico | — | $99 |
| 2024-07-26 | 483 Form 483 | ALBUQUERQUE, New Mexico | 8 | $99 |
Investigators on these documents
FEI number 1629960 · most recent document Dec 18, 2024
About Sombra Cosmetics Inc.
How many FDA Form 483s has Sombra Cosmetics Inc. received?
FDA Intel has 1 Form 483 on file for Sombra Cosmetics Inc.; the most recent is dated Jul 26, 2024.
When was Sombra Cosmetics Inc. last inspected by FDA?
The most recent FDA inspection document on file for Sombra Cosmetics Inc. is a Form 483 dated Jul 26, 2024, for the site in ALBUQUERQUE, New Mexico.
What did FDA cite at Sombra Cosmetics Inc.?
The regulations cited most in the observations on file for Sombra Cosmetics Inc. are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.160(b) (General requirements), 1 time; 21 CFR 211.165(e) (Testing and release for distribution), 1 time.
Has Sombra Cosmetics Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Sombra Cosmetics Inc.; the most recent is dated Dec 18, 2024.