# FDA 483 - National Therapy Products Inc. - April 20, 2023

Source: https://www.keypedia.com/records/483/national-therapy-products-inc/ecc1d273-663e-40c6-b56f-d325b4b3361b

> FDA 483 for National Therapy Products Inc. on April 20, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: National Therapy Products Inc.
- Inspection Date: 2023-04-20
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: National Therapy Products Inc. in Brampton, Ontario, a medical device manufacturer, was cited for significant deficiencies during an FDA inspection. The inspection revealed issues with maintaining design history files, device master records for ultrasound gels, and proper documentation of corrective and preventive actions. These findings indicate a lack of adherence to quality system requirements for medical device manufacturing.

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/national-therapy-products-inc/2de1222b-aa0d-4437-9626-62168de0b330

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd