FDA 483 - Penner Mfg Inc - February 11, 2025

Penner Patient Care, Inc. in Aurora, NE, was cited for significant quality system deficiencies during an FDA inspection related to their Class II Hydro-Massage Bath. Observations included a failure to apply unique device identifiers to product labels and a lack of established procedures for corrective and preventive actions. The firm also failed to ensure timely submission of medical device reports and did not establish requirements for suppliers.