# FDA 483 - Dharma Research, Inc. - December 11, 2024

Source: https://www.keypedia.com/records/483/dharma-research-inc/8c6be09a-ff38-4125-97e6-2d24ef168c87

> FDA 483 for Dharma Research, Inc. on December 11, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dharma Research, Inc.
- Inspection Date: 2024-12-11
- Product Type: drugs
- Office Name: Florida District Office
- Summary: Dharma Research, Inc. in Miami, FL, a medical device manufacturer, was cited for significant quality system deficiencies during an FDA inspection. Observations included a failure to document design validation results in the design history file and master batch records, discrepancies between device history records and master records regarding manufacturing conditions, and a lack of documented corrective and preventive actions for product complaints. These issues indicate a need for improved adherence to quality system regulations.

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## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.keypedia.com/companies/dharma-research-inc/548c3b8a-f5b8-4b54-a899-a23f794fd666

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9