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# Multiple Violations at Dr. Joel Kaplan Inc.
- URL: https://www.fdaweb.com/multiple-violations-at-dr-joel-kaplan-inc/
- Published: 2024-01-16T12:00:00.000Z
- Updated: 2026-09-14T14:20:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156136

A 6/27-6/30/2023 FDA inspection at Dr. **Joel Kaplan** Inc. in San Diego, CA, determined there were multiple violations in the firm’s manufacturing and distribution of several male and female sexual health enhancement devices. A 1/8 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dr-joel-kaplan-inc-667193-01082024?ref=fdaweb.com) discusses information from the devices’ product inserts and the company’s Web site that establishes that the products are legally considered to be medical devices subject to FDA regulation. The letter says the product classifications and codes assigned to the products are not consistent with their intended uses.

FDA says the products are adulterated because the company does not have an approved PMA or IDE in place for them. They are misbranded, it says, because the firm did not notify the agency of its intent to introduce the products into commercial distribution.

The letter also lists these Quality System Regulation violations:

- failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failing to establish and maintain design history files;
- failing to establish and maintain procedures for acceptance activities;
- failing to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
- failing to adequately establish procedures for management review; and
- failing to conduct quality audits to assure that the quality system complies with the established quality system requirements and to determine the quality system’s effectiveness.

The letter says the adequacy of the firm’s responses to the inspection observations cannot be assessed due to inadequate submission of evidence. It also discusses multiple listing violations found for the products.

Dr. Kaplan Inc. was told to correct the violations promptly and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the corrections or corrective actions, and a timetable for completing the corrections.