# FDA 483 - Cross Brands Contract Filling, LLC - July 19, 2021

Source: https://www.keypedia.com/records/483/cross-brands-contract-filling-llc/0f106d76-24b3-4161-a0e4-26d9ef23eced

> FDA 483 for Cross Brands Contract Filling, LLC on July 19, 2021. 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: 2021-07-19
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Cross Brands Contract Filling, LLC, an OTC drug manufacturer in West Melbourne, FL, received a Form 483 citing significant deficiencies across its quality, laboratory, facilities, and production systems. Observations included failures to investigate microbial contamination, inadequate quality control oversight, insufficient laboratory controls for product testing and stability, and unvalidated cleaning and manufacturing processes. These issues indicate a severe lack of adherence to CGMP requirements.

## Related Documents

- [483 - 2019-06-10](https://www.keypedia.com/records/483/cross-brands-contract-filling-llc/1f12adcb-6257-4b1d-a613-9711f5bfb404)
- [WARNING_LETTER - 2019-06-10](https://www.keypedia.com/records/warning_letter/cross-brands-contract-filling-llc/79d8bc4f-5958-4f9b-91ff-fd8bcf7dbe14)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)
- [Saundra A. Munroe](https://www.keypedia.com/people/saundra-a-munroe/8e9b8973-5ac4-4a2a-ab26-1618c0e434e7)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6