FDA Inspection
Elba, Inc.Elba, Inc. – FDA Inspection, Sep 27, 2012
Record Details
This FDA Inspection record concerns Elba, Inc., with an inspection on September 27, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Elba, Inc.
- Inspection Date
- September 27, 2012
- Product Type
- Drugs
View Company Profile
ID · 75c86d0a-11e0-4486-8e1b-f436d134b7d8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 800164
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
- 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 |
| June 1, 2011 | 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 727271 - 2011-06-01
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