FDA Inspection
Elba, Inc.Elba, Inc. – FDA Inspection, Apr 2, 2010
Record Details
This FDA Inspection record concerns Elba, Inc., with an inspection on April 2, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Elba, Inc.
- Inspection Date
- April 2, 2010
- Product Type
- Drugs
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ID · 46ec4392-bfc0-4573-bf53-e06fce8ea2c3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 657193
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.180(e)(2)Review of problem drugs
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Elba, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2025 | OAI | Detroit District Office | Drug Quality Assurance |
| 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 |
Other documents for Elba, Inc.
- FDA Inspection 1269782 - 2025-05-13
- FDA Inspection 1130439 - 2020-09-15
- FDA Inspection 1029307 - 2017-10-05
- FDA Inspection 866873 - 2014-03-20
- FDA Inspection 800164 - 2012-09-27
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