# FDA 483 - Medley Pharmaceuticals Limited - May 19, 2023

Source: https://www.globalkeysolutions.net/records/483/medley-pharmaceuticals-limited/64d9845e-fe91-4da9-9182-c71512cd4f3d

> FDA 483 for Medley Pharmaceuticals Limited on May 19, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medley Pharmaceuticals Limited
- Inspection Date: 2023-05-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Medley Pharmaceuticals Limited, a drug manufacturer in Daman, India, was cited for significant deficiencies across its quality control and manufacturing operations. Observations included inadequate investigations into out-of-specification results and incidents, insufficient process control procedures, and failures in equipment cleaning validation. Additionally, the firm lacked proper environmental controls and procedures to prevent microbial contamination in non-sterile drug products.

## Related Officers

- [Teresa I. Navas](https://www.globalkeysolutions.net/people/teresa-i-navas/43f747c0-18c2-4630-bab9-936204aa93aa)

Company: https://www.globalkeysolutions.net/companies/medley-pharmaceuticals-limited/e3271248-7900-4155-a7db-66f64fa0936b

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1