# FDA 483 - U.S. Continental Marketing, Inc. - July 21, 2022

Source: https://www.globalkeysolutions.net/records/483/us-continental-marketing-inc/bb1ac4d7-f137-4025-9bc2-c11a200c1319

> FDA 483 for U.S. Continental Marketing, Inc. on July 21, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: U.S. Continental Marketing, Inc.
- Inspection Date: 2022-07-21
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: U.S. Continental Marketing, Inc. in Corona, CA, was inspected and cited for multiple deficiencies across its quality control, personnel training, labeling, and equipment systems. The inspection revealed a lack of written procedures, inadequate training records, uncontrolled label storage, and unperformed equipment qualifications, indicating significant non-compliance with cGMP regulations. These issues collectively point to a systemic failure in maintaining proper controls for drug product manufacturing.

## Related Documents

- [483 - 2018-10-30](https://www.globalkeysolutions.net/records/483/us-continental-marketing-inc/e36e2877-6bb1-4d41-b7a6-1942550eafb5)
- [WARNING_LETTER - 2018-10-30](https://www.globalkeysolutions.net/records/warning_letter/us-continental-marketing-inc/3332bc4d-2a56-40ba-a7a6-2ea9d732fffe)
- [483 - 2021-03-18](https://www.globalkeysolutions.net/records/483/us-continental-marketing-inc/14d8399e-d512-4a9b-8739-a3f6be6f5d06)

## Related Officers

- [https://www.fda.gov/media/120628/download](https://www.globalkeysolutions.net/people/santiago-gallardo-johnson/f5086b0c-c8fc-44dd-8d12-6506b9dd313f)

Company: https://www.globalkeysolutions.net/companies/us-continental-marketing-inc/2202462e-0004-4f6d-bc79-0bd1c3ac88c2

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