# FDA 483 - Malladi Drugs & Pharmaceuticals Ltd. Unit 1 - Unknown Date

Source: https://www.keypedia.com/records/483/malladi-drugs-pharmaceuticals-ltd-unit-1/45d689d3-a9af-4007-8787-a5a2c53714c6

> FDA 483 for Malladi Drugs & Pharmaceuticals Ltd. Unit 1 on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Malladi Drugs & Pharmaceuticals Ltd. Unit 1
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Malladi Drugs & Pharmaceuticals Limited in Ranipet, India, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to conduct thorough OOS investigations, implemented process changes without formal control, and exhibited inadequate process validation. Additionally, the facility had contamination risks, poor equipment maintenance, and inaccurate raw material records, indicating a broad lack of GMP compliance.

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Company: https://www.keypedia.com/companies/malladi-drugs-pharmaceuticals-ltd-unit-1/d873e90f-40dd-4648-905e-b86a086170aa

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321