FDA Inspection
Eagle Distributors Inc.Eagle Distributors Inc. – FDA Inspection, Jan 11, 2018
Record Details
This FDA Inspection record concerns Eagle Distributors Inc., with an inspection on January 11, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9f25fb51-e88b-4095-a7ea-1a7267ac7af3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037398
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.188(b)(7)Documentation of Actual Yield and Theoretical Yield
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Eagle Distributors Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 22, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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