FDA Inspection
James Medical Equipment LtdJames Medical Equipment Ltd – FDA Inspection, Jan 26, 2011
Record Details
This FDA Inspection record concerns James Medical Equipment Ltd, with an inspection on January 26, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- James Medical Equipment Ltd
- Inspection Date
- January 26, 2011
- Product Type
- Drugs
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ID · bb55aa0b-c9eb-4bc9-a336-bea51c94550f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 708258
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.198(b)Maintenance of Complaint File
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.134(a)Correct labels during finishing operations
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
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