483
Arch Medical Solutions - ElkhartArch Medical Solutions - Elkhart – FDA 483, Dec 18, 2024
Record Details
Arch Medical Solutions - Elkhart received a Form FDA 483 with four observations related to deficiencies in their quality system. The inspection revealed issues with controlling nonconforming product, inadequate rationale for "use-as-is" dispositions, and a failure to evaluate changes to a validated process. Additionally, the firm's complaint handling procedures were found to be inadequate, with undocumented investigations and inconsistent documentation methods.
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ID · b302bb56-b2c0-4739-9f0b-462dfdb6a9d2
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