483
Robert's Oxygen Company Inc.Robert's Oxygen Company Inc. – FDA 483, Apr 10, 2019
Record Details
Robert's Oxygen Company Inc. in Charlotte, NC, was inspected regarding its medical and food grade gas manufacturing operations. The inspection revealed a significant deficiency in batch production and control records, specifically the absence of complete labeling control records for drug products. This indicates a failure to maintain proper documentation for the labeling and lot numbering of manufactured medical and food grade gases.
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- Atlanta District Office
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ID · 943dd70c-2c60-4fdc-b9d7-9b4402e72886
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