# FDA 483 - Lee Pharma Ltd. - November 02, 2018

Source: https://www.globalkeysolutions.net/records/483/lee-pharma-ltd/79200c8f-40d2-4f65-a7b4-7a03f9a69738

> FDA 483 for Lee Pharma Ltd. on November 02, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lee Pharma Ltd.
- Inspection Date: 2018-11-02
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Lee Pharma Limited, a manufacturer in Hyderabad, India, revealed significant deficiencies in their quality control systems. The firm was cited for failing to validate analytical methods used for process validation and stability samples, and for inadequate storage conditions and packaging simulation for stability samples. Additionally, the inspection found issues with establishing reexamination periods for packaging materials and with written procedures lacking sufficient detail for consistent implementation.

## Related Officers

- [Tiara N Brown-Crosen](https://www.globalkeysolutions.net/people/tiara-n-brown-crosen/8255649d-25a9-49fa-a28d-0cdda922c0c3)

Company: https://www.globalkeysolutions.net/companies/lee-pharma-ltd/48104c9b-d659-4a58-8a3f-877f3f89cb69

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