FDA Inspection
Gopers Int LLCGopers Int LLC – FDA Inspection, Sep 30, 2014
Record Details
This FDA Inspection record concerns Gopers Int LLC, with an inspection on September 30, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Gopers Int LLC
- Inspection Date
- September 30, 2014
- Product Type
- Drugs
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ID · febbba26-d302-44da-abc7-dcbbb072dcf1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 898196
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.34Consultant Records
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
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Other FDA inspections of Gopers Int LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 26, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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