# FDA 483 - Cross Brands Contract Filling, LLC - June 10, 2019

Source: https://www.keypedia.com/records/483/cross-brands-contract-filling-llc/1f12adcb-6257-4b1d-a613-9711f5bfb404

> FDA 483 for Cross Brands Contract Filling, LLC on June 10, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cross Brands Contract Filling, LLC
- Inspection Date: 2019-06-10
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Cross-Brands Manufacturing LLC in Rockledge, FL, an OTC drug product manufacturer, revealed numerous significant deficiencies in its quality control unit and manufacturing processes. The firm failed to establish and follow written procedures for critical operations, including component testing, microbial control, equipment cleaning, and product release. These widespread issues indicate a severe lack of adherence to Good Manufacturing Practices, posing potential risks to the quality and safety of their OTC drug products.

## Related Documents

- [WARNING_LETTER - 2019-06-10](https://www.keypedia.com/records/warning_letter/cross-brands-contract-filling-llc/79d8bc4f-5958-4f9b-91ff-fd8bcf7dbe14)
- [483 - 2021-07-19](https://www.keypedia.com/records/483/cross-brands-contract-filling-llc/0f106d76-24b3-4161-a0e4-26d9ef23eced)

## Related Officers

- [Libia Lugo](https://www.keypedia.com/people/libia-lugo/55f1387e-b6bd-41ca-8507-45829629dac5)

Company: https://www.keypedia.com/companies/cross-brands-contract-filling-llc/39f3c715-d8dd-4057-b9d1-63548c433485

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9