FDA Inspection
Chemisphere CorporationChemisphere Corporation – FDA Inspection, Apr 5, 2010
Record Details
This FDA Inspection record concerns Chemisphere Corporation, with an inspection on April 5, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Chemisphere Corporation
- Inspection Date
- April 5, 2010
- Product Type
- Drugs
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ID · b15f2300-62b3-452e-8104-c3410d0ab0f0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 655435
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
15- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.84(d)(2)Component identification test
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.186(b)(7)Theoretical Yield and Percentages
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Other FDA inspections of Chemisphere Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2025 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 17, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 8, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 16, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Chemisphere Corporation
- FDA Inspection 1276805 - 2025-06-24
- FDA Inspection 1122817 - 2020-03-17
- FDA Inspection 926167 - 2015-05-08
- FDA Inspection 743248 - 2011-09-16
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