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

Source: https://www.keypedia.com/records/483/dr-joel-kaplan-inc/c62db39b-4505-4de9-8265-5066f6e74397

> FDA 483 for Dr. Joel Kaplan Inc. on June 30, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Joel Kaplan Inc.
- Inspection Date: 2023-06-30
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Dr. Joel Kaplan Inc. in San Diego, CA, a specification developer of E.D. systems and light therapy wraps, revealed seven significant quality system deficiencies. The firm failed to establish fundamental procedures for complaint handling, design control, acceptance activities, supplier management, product identification, management review, and quality audits. These observations indicate a severe lack of basic quality system controls.

## Related Documents

- [WARNING_LETTER - 2013-07-17](https://www.keypedia.com/records/warning_letter/dr-joel-kaplan-inc/a4ff8472-309f-4017-868d-ffd3f515db4e)
- [WARNING_LETTER - 2023-06-30](https://www.keypedia.com/records/warning_letter/dr-joel-kaplan-inc/af1192e5-b6e9-447c-be97-dc1ca93596df)

## Related Officers

- [Juanj Wu](https://www.keypedia.com/people/juanj-wu/0d3e8970-b524-49f6-a307-079091b3c91d)

Company: https://www.keypedia.com/companies/dr-joel-kaplan-inc/510e74ae-4746-4c40-a00e-b9b11fc7fae2

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6