FDA Inspection
Ei LLCEi LLC – FDA Inspection, Oct 6, 2017
Record Details
This FDA Inspection record concerns Ei LLC, with an inspection on October 6, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · bc3fa7b3-151f-42c0-815f-3c21cc73bdcb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1028163
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.42(b)Product flow through building is inadequate
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.67(b)(1)Cleaning SOP/responsibility
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Other FDA inspections of Ei LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 8, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 26, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 19, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 15, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 25, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ei LLC
- FDA Inspection 925800 - 2015-05-08
- FDA Inspection 870367 - 2014-02-26
- FDA Inspection 799551 - 2012-09-19
- FDA Inspection 745354 - 2011-09-15
- FDA Inspection 729179 - 2011-05-25
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