# FDA 483 - Dharma Research, Inc. - September 30, 2022

Source: https://www.keypedia.com/records/483/dharma-research-inc/eff499fd-5fd4-4762-952b-88439345a244

> FDA 483 for Dharma Research, Inc. on September 30, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dharma Research, Inc.
- Inspection Date: 2022-09-30
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Pharma Research, Inc. in Miami, FL, an OTC and prescription drug manufacturer, received a Form 483 with five observations highlighting significant deficiencies in their manufacturing and quality control processes. The inspection revealed issues including inadequate laboratory controls for water specifications, lack of process validation for drug products, and failure to test for objectionable microorganisms. Additionally, the firm's quality control unit did not follow procedures for deviations, change controls, and allowed the use of unreleased and expired materials, indicating a systemic breakdown in their quality system.

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## Related Officers

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6