# FDA WARNING_LETTER - Orean Personal Care Ltd. - March 15, 2024

Source: https://www.keypedia.com/records/warning_letter/orean-personal-care-ltd/ec1fd50b-9038-4830-83f0-948def9be2dd

> FDA WARNING_LETTER for Orean Personal Care Ltd. on March 15, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Orean Personal Care Ltd.
- Inspection Date: 2024-03-15
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On August 29, 2024, the FDA issued a Warning Letter to Orean Personal Care Ltd. following an inspection from March 11-15, 2024, at their Cleckheaton, UK facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include:
1.  **Failure to test components for identity and conformity (21 CFR 211.84(d)(1) and 211.84(d)(2))**: The firm did not perform adequate identity testing for each component lot, including the API for OTC drug products, and relied on supplier COAs without validating their reliability. This is a repeat finding from a 2017 inspection. The firm's response was inadequate, lacking specificity on testing plans and a retrospective risk assessment for products on the market.
2.  **Failure to establish adequate written procedures for production, process control, cleaning, and maintenance (21 CFR 211.100(a) and 211.67(b))**:
    *   **Lack of Process Validation**: The firm failed to adequately validate manufacturing processes, a repeat finding from 2017. Their response lacked supportive documentation, timelines, and a retrospective

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- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.keypedia.com/companies/orean-personal-care-ltd/5db78986-af8c-4b54-a9da-ed9aaf3b6859

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c