# FDA 483 - Innocore Sales & Marketing Inc. - April 25, 2025

Source: https://www.keypedia.com/records/483/innocore-sales-marketing-inc/306e00bc-7842-45f3-8102-37cd53d24ee8

> FDA 483 for Innocore Sales & Marketing Inc. on April 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Innocore Sales & Marketing Inc.
- Inspection Date: 2025-04-25
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Innocore Sales & Marketing Inc., a human drug manufacturer in Woodstock, was cited for numerous significant deficiencies during an FDA inspection. The observations highlight critical failures in process validation, component identity testing, test method validation, equipment maintenance, and quality control record-keeping, with several issues being repeat observations from a prior inspection. These findings indicate a lack of adequate controls to ensure the quality, safety, and purity of their drug products.

## Related Documents

- [483 - 2019-06-06](https://www.keypedia.com/records/483/innocore-sales-marketing-inc/47143618-114f-487b-8fba-f57f3d94b1b9)
- [WARNING_LETTER - 2025-04-25](https://www.keypedia.com/records/warning_letter/innocore-sales-marketing-inc/dea81987-87a2-41e8-84c3-9be0477298f0)

## Related Officers

- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.keypedia.com/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)

Company: https://www.keypedia.com/companies/innocore-sales-marketing-inc/a07a64a3-3870-4c22-ae98-196920c049b0

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8