# FDA 483 - U.S. Continental Marketing, Inc. - March 18, 2021

Source: https://www.keypedia.com/records/483/us-continental-marketing-inc/14d8399e-d512-4a9b-8739-a3f6be6f5d06

> FDA 483 for U.S. Continental Marketing, Inc. on March 18, 2021. 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: 2021-03-18
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: U.S. Continental Marketing, Inc., a repacker and relabeler in Corona, CA, was cited for multiple significant deficiencies during an FDA inspection. Observations included a lack of stability data for expiration dates, inadequate quality control unit procedures, insufficient employee training, poor label control, and failures in equipment cleaning and qualification. These issues indicate a systemic lack of adherence to good manufacturing practices.

## Related Documents

- [483 - 2018-10-30](https://www.keypedia.com/records/483/us-continental-marketing-inc/e36e2877-6bb1-4d41-b7a6-1942550eafb5)
- [WARNING_LETTER - 2018-10-30](https://www.keypedia.com/records/warning_letter/us-continental-marketing-inc/3332bc4d-2a56-40ba-a7a6-2ea9d732fffe)
- [483 - 2022-07-21](https://www.keypedia.com/records/483/us-continental-marketing-inc/bb1ac4d7-f137-4025-9bc2-c11a200c1319)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

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

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