FDA Inspection
General OrganicsGeneral Organics – FDA Inspection, Sep 3, 2009
Record Details
This FDA Inspection record concerns General Organics, with an inspection on September 3, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- General Organics
- Inspection Date
- September 3, 2009
- Product Type
- Drugs
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ID · 92345b8f-2ffc-4c0f-97a4-0820e950a304
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 609615
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.82(b)Quarantine Storage of Components
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.130(c)Lot or control number assigned
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Other FDA inspections of General Organics
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for General Organics
- FDA Inspection 672593 - 2010-07-21
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