# FDA 483 - Torbay Pharmaceuticals, Ltd. - November 12, 2024

Source: https://www.keypedia.com/records/483/torbay-pharmaceuticals-ltd/6299b0c8-7538-4597-bb10-de12ad1cc987

> FDA 483 for Torbay Pharmaceuticals, Ltd. on November 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Torbay Pharmaceuticals, Ltd.
- Inspection Date: 2024-11-12
- Product Type: drugs
- Office Name: Foreign - CDER (Non-Bioresearch Monitoring)
- Summary: During an inspection conducted from November 4 to November 12, 2024, the U.S. Food and Drug Administration (FDA) identified significant observations at Torbay Pharmaceuticals, Ltd., a drug product manufacturer in Paignton, United Kingdom. The inspection revealed critical issues regarding the firm's adherence to current Good Manufacturing Practices (cGMP).
A primary concern was the company's failure to thoroughly investigate unexplained discrepancies, specifically the persistent presence of particles in multiple batches of a sterile injection product. Despite numerous rejected vials, no root cause investigation was conducted.
The FDA also noted serious deficiencies within the quality control unit, including a lack of oversight on GMP data integrity. Investigators found uncontrolled and discarded documents, such as laboratory printouts and batch reports, indicating poor document control. Furthermore, the firm did not provide a complete Piping and Instrumentation Diagram for its critical water system.
Equipment maintenance and cleaning practices were found to be inadequate, with rust-like discoloration observed within the aseptic filling zone, posing a contamination risk. The filling line's design necessitated frequent unplanned operator interventions in the aseptic area due to liquid pooling. Additionally, a recovery study supporting cleaning validation activities was deemed insufficient.
Finally, the inspection identified deficiencies in aseptic processing area environmental controls, specifically an inadequate airflow pattern study that failed to properly assess critical zones and potential impacts of interventions. Torbay Pharmaceuticals, Ltd. must promptly address these observations with comprehensive corrective and preventive actions to ensure product quality, safety, and regulatory compliance.

## Related Documents

- [483 - 2024-11-12](https://www.keypedia.com/records/483/torbay-pharmaceuticals-ltd/0bc392e6-30c2-45df-8775-96b37f272fc3)

## Related Officers

- [Damaris Y. Hernandez](https://www.keypedia.com/people/damaris-y-hernandez/ca16093e-047b-4bf1-bcc1-c439cff21e8a)
- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

Company: https://www.keypedia.com/companies/torbay-pharmaceuticals-ltd/761a8c36-ef50-487f-99f1-a6800e5cbbe8

Office: https://www.keypedia.com/offices/foreign-cder-non-bioresearch-monitoring/279f5818-f62e-40c9-951c-cfbc7f929fa1