FDA Inspection
Ei LLCEi LLC – FDA Inspection, May 8, 2015
Record Details
This FDA Inspection record concerns Ei LLC, with an inspection on May 8, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Ei LLC
- Inspection Date
- May 8, 2015
- Product Type
- Drugs
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ID · f69030db-51d3-4c57-ac23-96e808fd99ea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 925800
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Ei LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 6, 2017 | OAI | Center for Drug Evaluation and Research | New Drug Evaluation |
| 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 1028163 - 2017-10-06
- 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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