FDA Inspection
PharmaCare Health ServicesPharmaCare Health Services – FDA Inspection, Nov 2, 2010
Record Details
This FDA Inspection record concerns PharmaCare Health Services, with an inspection on November 2, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- PharmaCare Health Services
- Inspection Date
- November 2, 2010
- Product Type
- Drugs
View Company Profile
ID · ddae0ccb-58c4-4379-b217-e8871c33bf25
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 702583
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.82(a)Examination on receipt, before acceptance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.134(c)Examinations documented
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.100(a)Approval and review of procedures
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