FDA Inspection
Woodhaven Pharmacy Services, LLC dba Remedi SeniorCareWoodhaven Pharmacy Services, LLC dba Remedi SeniorCare – FDA Inspection, Mar 19, 2009
Record Details
This FDA Inspection record concerns Woodhaven Pharmacy Services, LLC dba Remedi SeniorCare, with an inspection on March 19, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 19, 2009
- Product Type
- Drugs
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ID · f989f885-6ae3-4ee4-86c3-4562ab797036
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 565081
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
41- 21 CFR 211.46(d)Penicillin air handling systems not kept separate
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.188(b)(9)Description of containers and closures
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.188(b)(6)Inspection of packaging and labeling area
- 21 CFR 211.198(a)Quality Control Review
- 21 CFR 211.198(a)Adverse Drug Experience
- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.137(a)Expiration date lacking
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