FDA 483 - Dr. Joel Kaplan Inc. - June 30, 2023

During an inspection conducted by the FDA from June 27-30, 2023, Dr. Joel Kaplan Inc., a medical device specification developer based in San Diego, CA, received a Form FDA-483 detailing seven significant observations. The report, issued to President and CEO Shmuel Itshaki, highlighted multiple deficiencies in the company's quality management system, falling under the regulatory framework of FDA's Quality System Regulation for medical devices.

The primary violations included a failure to establish and follow adequate procedures for complaint handling; specific customer complaints were not documented or investigated as required. Crucially, the firm lacked essential design history files (DHF) and device master records (DMR) for several products, such as the Dr. JOEL KAPLAN Metal Hand Pump E.D. System and STIMULATE Red Light Therapy Wrap.

Further issues involved the absence of established procedures for acceptance activities, leading to a lack of Device History Records (DHR) and final acceptance documentation. Supplier management was also deficient, with no approved supplier list or vendor evaluation records available. Product traceability was compromised as distributed devices lacked necessary identification numbers for manufacturing dates, lots, or batches. Additionally, the company failed to establish procedures and maintain records for critical quality system elements like management reviews and internal quality audits. Dr. Joel Kaplan Inc. has indicated a commitment to correcting all identified observations.