Progressive Home Medical Equipment Inc. – FDA Inspection, Jun 21, 2013

Record Details

This FDA Inspection record concerns Progressive Home Medical Equipment Inc., with an inspection on June 21, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Progressive Home Medical Equipment Inc.
Inspection Date: June 21, 2013
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · 7a5d9cae-844e-4d21-9773-0df81a748eaa

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 845242
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.25(a)GMP Training Frequency
21 CFR 211.25(c)Inadequate number of personnel
21 CFR 211.100(a)Absence of Written Procedures
21 CFR 211.192Investigations of discrepancies, failures
21 CFR 211.22(a)Lack of quality control unit
21 CFR 211.150Written distribution procedure

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FDA Inspection

Progressive Home Medical Equipment Inc.June 21, 2013