FDA Inspection
Sage Pharmaceuticals, Inc.Sage Pharmaceuticals, Inc. – FDA Inspection, May 6, 2011
Record Details
This FDA Inspection record concerns Sage Pharmaceuticals, Inc., with an inspection on May 6, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sage Pharmaceuticals, Inc.
- Inspection Date
- May 6, 2011
- Product Type
- Drugs
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ID · 6931b592-9c50-4b64-98b9-62c438f1d4bf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 724336
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
13- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.110(a)Control procedures fail to include the following
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.182Specific information required in individual logs
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
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Other FDA inspections of Sage Pharmaceuticals, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 17, 2012 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| April 22, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sage Pharmaceuticals, Inc.
- FDA Inspection 768299 - 2012-02-17
- FDA Inspection 577809 - 2009-04-22
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