Sombra Cosmetics Inc.
Form 483 issued July 26, 2024 · ALBUQUERQUE, New Mexico
- Inspection
- Jul 15 – Jul 26, 2024
- Investigator
- Carolina D. Vasquez
- Observations
- 8
- Pages
- 7
- FEI number
- 1629960
In short: On July 26, 2024, FDA issued a Form 483 with 8 observations to Sombra Cosmetics Inc. in ALBUQUERQUE, New Mexico (FEI 1629960) after an inspection that ran Jul 15 – Jul 26, 2024. The investigator was Carolina D. Vasquez. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
Investigations of an unexplained discrepancy did not extend to other batches of…
- 04
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
This inspection in context
Carolina D. Vasquez
9 documents · 2022–2026
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in California.
The firmSombra Cosmetics Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sombra Cosmetics Inc.?
FDA listed 8 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Sombra Cosmetics Inc.?
Carolina D. Vasquez is named on this Form 483, for the inspection of Jul 15 – Jul 26, 2024. Each investigator has a profile showing what they cite most.
When was Sombra Cosmetics Inc. inspected by FDA?
The inspection ran Jul 15 – Jul 26, 2024, and the Form 483 is dated July 26, 2024.
How do I get the full Form 483 for Sombra Cosmetics Inc.?
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.