FDA Inspection
James Medical Equipment LtdJames Medical Equipment Ltd – FDA Inspection, May 18, 2012
Record Details
This FDA Inspection record concerns James Medical Equipment Ltd, with an inspection on May 18, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- James Medical Equipment Ltd
- Inspection Date
- May 18, 2012
- Product Type
- Drugs
View Company Profile
ID · 48833487-7e2b-48e7-9d5f-69f4da7eef56
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 784152
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Approval and review of procedures
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