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

Source: https://www.keypedia.com/records/warning_letter/cross-brands-contract-filling-llc/79d8bc4f-5958-4f9b-91ff-fd8bcf7dbe14

> FDA WARNING_LETTER 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: WARNING_LETTER
- Company Name: Cross Brands Contract Filling, LLC
- Inspection Date: 2019-06-10
- Product Type: Drugs
- Office Name: Office of Pharmaceutical Quality
- Summary: On December 17, 2019, the FDA issued a Warning Letter to Cross-Brands Manufacturing LLC following an inspection from June 6-10, 2019, at their Rockledge, Florida facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include:
1.  **Failure to verify component identity and validate supplier analyses (21 CFR 211.84(d)(1) and (2)):** The firm did not test raw materials for OTC sunscreens and topical salicylic acid products, relying solely on vendor Certificates of Analysis (COA) without validation.
2.  **Inadequate Quality Control Unit (21 CFR 211.22):** The Quality Unit (QU) lacked sufficient oversight, written procedures, and failed to ensure complete batch and laboratory records. The QU also misrepresented microbiological test results (e.g., for *Staphylococcus aureus* and *Pseudomonas aeruginosa*) on COAs released to customers.
3.  **Failure to conduct microbiological testing of components (21 CFR 211.84(d)(6)):** The firm lacked a monitoring program for the microbiological quality of water used in topical drug products.

The FDA also identified significant data integrity issues, recommending the retention of a qualified consultant for remediation.

Furthermore, several products, including “(b)(

## Related Documents

- [483 - 2019-06-10](https://www.keypedia.com/records/483/cross-brands-contract-filling-llc/1f12adcb-6257-4b1d-a613-9711f5bfb404)
- [483 - 2021-07-19](https://www.keypedia.com/records/483/cross-brands-contract-filling-llc/0f106d76-24b3-4161-a0e4-26d9ef23eced)

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/rebecca-asente/0a82a46d-3e13-4a51-8abe-58955bb0095e)
- [Renee Alsobrook](https://www.keypedia.com/people/renee-alsobrook/2ecfa488-4a0e-46bd-af85-a5a43456f225)
- [John W. Diehl, M.S.Program Division](https://www.keypedia.com/people/john-w-diehl/83ce50c4-b3cb-42ca-96eb-0c988068e08f)
- [Program Division Director](https://www.keypedia.com/people/monica-r-maxwell/e1b3373a-80b0-4023-9aea-b4ac7170c964)

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

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality/c3303908-9657-4cd3-ae43-2458c98e8a64