FDA Inspection
Polysciences, Inc.Polysciences, Inc. – FDA Inspection, Apr 29, 2015
Record Details
This FDA Inspection record concerns Polysciences, Inc., with an inspection on April 29, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Polysciences, Inc.
- Inspection Date
- April 29, 2015
- Product Type
- Drugs
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ID · 84e3be95-295d-4e78-baed-fbd554b2815e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 924102
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.188(b)(4)Weights and measures of components used
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Polysciences, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 12, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 24, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Polysciences, Inc.
- FDA Inspection 1082540 - 2019-03-12
- FDA Inspection 668660 - 2010-06-24
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