# FDA 483 - Kareway Product Inc - March 28, 2019

Source: https://www.keypedia.com/records/483/kareway-product-inc/514e29a7-5001-4732-ac35-498021652615

> FDA 483 for Kareway Product Inc on March 28, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kareway Product Inc
- Inspection Date: 2019-03-28
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Kareway Product Inc, an OTC-Monograph Drug Distributor in Compton, CA, was cited for failing to report serious adverse events for non-prescription drugs to the FDA. The firm received numerous reports of adverse drug events between 2013 and 2018, including irritation, swelling, and infection, but did not report any of these to the agency. This indicates a significant lapse in post-market surveillance and regulatory compliance.

## Related Officers

- [Business Analyst/Provider Enrollment Specialist](https://www.keypedia.com/people/lakecha-n-lewis/39b6305d-2a9f-448b-9a14-e412b43c8522)

Company: https://www.keypedia.com/companies/kareway-product-inc/b7e7f212-3a7c-4b63-a140-241077176c7d

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