# FDA 483 - Sumar Biotech LLP - Unknown Date

Source: https://www.keypedia.com/records/483/sumar-biotech-llp/296caf69-bb6e-4c51-849b-e292b328f8a4

> FDA 483 for Sumar Biotech LLP on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sumar Biotech LLP
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: SUMAR BIOTECH LLP, an intermediate manufacturer in Mehsana Sub-District, Gujarat, India, was cited for significant deficiencies across its quality control, laboratory operations, and production records. The inspection revealed a lack of established test methods, an inadequate stability program, poor laboratory control mechanisms including data integrity issues, and incomplete manufacturing documentation. These issues indicate a systemic failure to adhere to good manufacturing practices.

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Company: https://www.keypedia.com/companies/sumar-biotech-llp/b7f7f99f-fc7d-45c1-a2dd-699348bd0f42

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