FDA 483 - Hyland's Consumer Health Inc. - November 29, 2022

Hyland's Consumer Health Inc. in Los Angeles, CA, was inspected by the FDA, resulting in five observations related to quality system, production system, and laboratory system deficiencies. The inspection revealed issues with investigation records, process validation, complaint handling procedures, master production records, and verification of testing methods, indicating significant concerns across multiple aspects of their drug manufacturing operations.