# FDA 483 - U.S. Continental Marketing, Inc. - October 30, 2018

Source: https://www.keypedia.com/records/483/us-continental-marketing-inc/e36e2877-6bb1-4d41-b7a6-1942550eafb5

> FDA 483 for U.S. Continental Marketing, Inc. on October 30, 2018. 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: 2018-10-30
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of U.S. Continental Marketing, Inc., a contract OTC drug product labeler in Corona, CA, revealed significant deficiencies in their current good manufacturing practices. The firm failed to provide cGMP training to employees, maintain accurate batch production and control records, and adequately control drug product labeling operations. Additionally, the inspection found that written procedures for component handling were not followed, distribution records lacked essential lot numbers, and equipment maintenance and cleaning records were not kept.

## Related Documents

- [WARNING_LETTER - 2018-10-30](https://www.keypedia.com/records/warning_letter/us-continental-marketing-inc/3332bc4d-2a56-40ba-a7a6-2ea9d732fffe)
- [483 - 2021-03-18](https://www.keypedia.com/records/483/us-continental-marketing-inc/14d8399e-d512-4a9b-8739-a3f6be6f5d06)
- [483 - 2022-07-21](https://www.keypedia.com/records/483/us-continental-marketing-inc/bb1ac4d7-f137-4025-9bc2-c11a200c1319)

## Related Officers

- [Stephanie A. Slater](https://www.keypedia.com/people/stephanie-a-slater/f356e65c-3398-4688-8b86-4dcd4b9ae83b)

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