FDA Inspection
Elba, Inc.Elba, Inc. – FDA Inspection, Oct 5, 2017
Record Details
This FDA Inspection record concerns Elba, Inc., with an inspection on October 5, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- Emilie Kahn (Issuing Officer)
- Michelle L. Jones (Company Rep)
View Company Profile
ID · dc819489-af29-4809-899f-6d3025305777
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029307
- FDA center
- Foods & Cosmetics
- Project area
- Colors and Cosmetics Technology
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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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 |
| 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 1269782 - 2025-05-13
- FDA Inspection 1130439 - 2020-09-15
- FDA Inspection 866873 - 2014-03-20
- FDA Inspection 800164 - 2012-09-27
- FDA Inspection 727271 - 2011-06-01
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