# FDA 483 - Tioga Limited - September 21, 2023

Source: https://www.globalkeysolutions.net/records/483/tioga-limited/565dcd58-855e-4eb9-91b4-dad8b1392392

> FDA 483 for Tioga Limited on September 21, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tioga Limited
- Inspection Date: 2023-09-21
- Product Type: other
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Tioga Limited, a contract manufacturer in Derby, United Kingdom, revealed several deficiencies in their quality system. Observations included inadequate documentation of corrective and preventive actions and equipment maintenance, as well as issues with training procedures and the independence of internal auditors. These findings indicate a need for improved adherence to quality system requirements.

## Related Officers

- [Esteban Beltran](https://www.globalkeysolutions.net/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)

Company: https://www.globalkeysolutions.net/companies/tioga-limited/73c3e777-6d4d-4214-b409-923c39cada18

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd