FDA Inspection
ENDO Pharmaceuticals Solutions, Inc.ENDO Pharmaceuticals Solutions, Inc. – FDA Inspection, Oct 23, 2018
Record Details
This FDA Inspection record concerns ENDO Pharmaceuticals Solutions, Inc., with an inspection on October 23, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b2423310-a401-4fe5-8f08-d7c052e1fa13
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069481
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ENDO Pharmaceuticals Solutions, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2025 | VAI | New Jersey District Office | Drug Quality Assurance |
| March 4, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 21, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ENDO Pharmaceuticals Solutions, Inc.
- FDA Inspection 1258791 - 2025-01-17
- FDA Inspection 868436 - 2014-03-04
- FDA Inspection 758818 - 2011-12-21
- FDA Inspection 694965 - 2010-11-09
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