FDA Inspection
Care Medical and Rehabilitative Equipment, Inc.Care Medical and Rehabilitative Equipment, Inc. – FDA Inspection, Sep 24, 2009
Record Details
This FDA Inspection record concerns Care Medical and Rehabilitative Equipment, Inc., with an inspection on September 24, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 24, 2009
- Product Type
- Drugs
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ID · 87f0f2a1-bff2-486b-b52c-bfc5a3f9489d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 615713
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(a)Procedures To Be in Writing
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