FDA Inspection
OSI Pharmaceuticals, IncOSI Pharmaceuticals, Inc – FDA Inspection, Sep 22, 2010
Record Details
This FDA Inspection record concerns OSI Pharmaceuticals, Inc, with an inspection on September 22, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- OSI Pharmaceuticals, Inc
- Inspection Date
- September 22, 2010
- Product Type
- Drugs
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ID · ba434d45-89b5-4104-a186-2f61e9ffbcc5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 682629
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 314.80(c)(1)(ii)Submission of report follow-up
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
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