FDA Inspection
ENDO USA, IncENDO USA, Inc – FDA Inspection, Oct 28, 2013
Record Details
This FDA Inspection record concerns ENDO USA, Inc, with an inspection on October 28, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ENDO USA, Inc
- Inspection Date
- October 28, 2013
- Product Type
- Drugs
View Company Profile
ID · 528d7391-da51-4265-8c5d-52dddd37f0f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 851401
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 314.80(c)Failure by applicant to report ADE
- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of ENDO USA, Inc
8| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2025 | Not classified | New York District Office | |
| March 3, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 27, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 7, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 27, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ENDO USA, Inc
- FDA Inspection 1288360 - 2025-09-26
- FDA Inspection 1136893 - 2021-03-03
- FDA Inspection 963017 - 2016-01-27
- FDA Inspection 809209 - 2012-12-07
- FDA Inspection 764681 - 2012-01-27
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