FDA Inspection
Mercy Assisted Care, Inc.Mercy Assisted Care, Inc. – FDA Inspection, May 9, 2013
Record Details
This FDA Inspection record concerns Mercy Assisted Care, Inc., with an inspection on May 9, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Mercy Assisted Care, Inc.
- Inspection Date
- May 9, 2013
- Product Type
- Drugs
View Company Profile
ID · f5dc01b8-314d-4d5f-b04f-54ada11ad635
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 831272
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.122(a)Written procedures not followed
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