483
ContainMed, Inc.FDA 483 - ContainMed, Inc. - February 19, 2020
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ContainMed, Inc., a contract manufacturer in Indianapolis, IN, was inspected from February 12-19, 2020. The inspection revealed significant deficiencies in their quality system, particularly concerning the control of nonconforming product, rework procedures, and the maintenance of device history records. These issues indicate a lack of adequate documentation and established procedures for critical manufacturing and quality control processes.
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ID · 7cdf9e6c-578c-490f-b373-3a01ad418111