# FDA 483 - Malladi Drugs & Pharmaceuticals Ltd. Unit 1 - November 07, 2022

Source: https://www.globalkeysolutions.net/records/483/malladi-drugs-pharmaceuticals-ltd-unit-1/817c3f32-1c79-4a84-a529-814f1e7c40fb

> FDA 483 for Malladi Drugs & Pharmaceuticals Ltd. Unit 1 on November 07, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Malladi Drugs & Pharmaceuticals Ltd. Unit 1
- Inspection Date: 2022-11-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Malladi Drugs & Pharmaceuticals Limited, Unit-1 in Ranipet, India, revealed four significant observations related to manufacturing practices. Deficiencies included unscientific sampling procedures, inadequate validation protocols for equipment, lack of verification for critical cell count operations, and poor facility maintenance with visible contamination in a critical area. These issues indicate a need for improved quality control and facility upkeep.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/malladi-drugs-pharmaceuticals-ltd-unit-1/45d689d3-a9af-4007-8787-a5a2c53714c6)

## Related Officers

- [Wayne D. Mcgrath](https://www.globalkeysolutions.net/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Investigator](https://www.globalkeysolutions.net/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

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

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