FDA Inspection
Elba, Inc.Elba, Inc. – FDA Inspection, Mar 20, 2014
Record Details
This FDA Inspection record concerns Elba, Inc., with an inspection on March 20, 2014, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Elba, Inc.
- Inspection Date
- March 20, 2014
- Product Type
- Food/cosmetics
View Company Profile
ID · b2e9dd6d-6a66-4ba0-8bf9-bd5039ac994b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 866873
- FDA center
- Foods & Cosmetics
- Project area
- Colors and Cosmetics Technology
FDA Citations
12- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 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(c)Sampling and testing plans not described
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 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
Showing 10 of 12 citations.
Full citation text and observation details available on the Dashboard.
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 |
| 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 1029307 - 2017-10-05
- FDA Inspection 800164 - 2012-09-27
- FDA Inspection 727271 - 2011-06-01
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.