OXYGEN.7531W Ascher Health Care Center, Feasterville, PA, April 8 (Philadelphia). The agency faulted testing, record keeping, lot numbering and SOPs. 7532W Health Services, Massilon, OH, March 22 (Cincinnati). An inspection revealed deviations in calibration, assays, lot numbering, pre-fill operations, calibration and testing. Misbranding resulted from a lack of prescription labeling. 7533W Nichole Medical Equipment & Supply, Philadelphia, PA, April 8 (Philadelphia). Deficiencies involved testing, cali-bration, record keeping, lot numbering and SOPs. 7534W Shuman HealthCare, Waycross, GA, Jan. 5 (Atlanta). FDA cited problems with calibration, record review, training, calibration and control of labeling materials. Misbranding resulted from labeling deficiencies, the letter said. 7535W Spectrum Medical, Silver Spring, MD, March 19 (Baltimore). The agency cited deviations in testing, quarantining untested containers, SOPs, record keeping and lot numbering. |
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