FDA Inspection
Sombra Cosmetics, IncSombra Cosmetics, Inc – FDA Inspection, May 8, 2026
Record Details
This FDA Inspection record concerns Sombra Cosmetics, Inc, with an inspection on May 8, 2026, issued by the Denver District Office, covering human drugs.
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ID · 679bb353-b6de-41ae-ac87-69234c165346
Inspection Facts
- Inspection number
- 1313582
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of Sombra Cosmetics, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2024 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 26, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 26, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 7, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 21, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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