FDA Inspection
Elba, Inc.Elba, Inc. – FDA Inspection, May 13, 2025
Record Details
This FDA Inspection record concerns Elba, Inc., with an inspection on May 13, 2025, issued by the Detroit District Office, covering human drugs.
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ID · f7abaa33-7861-441e-b276-7cb77fa460dc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1269782
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Elba, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2020 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| October 5, 2017 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| March 20, 2014 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| September 27, 2012 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 1, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Elba, Inc.
- FDA Inspection 1130439 - 2020-09-15
- FDA Inspection 1029307 - 2017-10-05
- FDA Inspection 866873 - 2014-03-20
- FDA Inspection 800164 - 2012-09-27
- FDA Inspection 727271 - 2011-06-01
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