FDA 483 - RemedyRepack Inc. - November 10, 2022

RemedyRepack Inc. in Indiana, PA, a repackager/relabeler, was inspected by the FDA and received a Form 483 with six observations. The inspection revealed significant deficiencies in written procedures, including a lack of process validation, equipment qualification, cleaning validation, change control, and procedures for packaging component handling. Additionally, the firm failed to adequately investigate discrepancies and did not retain reserve samples for the required duration.