FDA Inspection
ALLERGAN SALES, LLCALLERGAN SALES, LLC – FDA Inspection, Apr 11, 2019
Record Details
This FDA Inspection record concerns ALLERGAN SALES, LLC, with an inspection on April 11, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a39dc4a3-907e-4a7e-b055-aafafa0e824d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086054
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- FDCA 505-1(e)(2)(A)Failure to comply with REMS Medication Guide
- FDCA 505-1(f)(4)Failure to comply with REMS Implementation System
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Other FDA inspections of ALLERGAN SALES, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 2, 2018 | VAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
| September 1, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for ALLERGAN SALES, LLC
- FDA Inspection 1095822 - 2019-06-06
- FDA Inspection 1050385 - 2018-05-02
- FDA Inspection 986938 - 2016-09-01
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