# FDA 483 - BioMylz Pvt. Ltd. - February 07, 2020

Source: https://www.keypedia.com/records/483/biomylz-pvt-ltd/c7e2694d-628f-437d-bdcf-9a90e2ef0a3a

> FDA 483 for BioMylz Pvt. Ltd. on February 07, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioMylz Pvt. Ltd.
- Inspection Date: 2020-02-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of BioMyz Pvt. Ltd. in Bangalore, India, from February 3-7, 2020, revealed extensive deficiencies across its drug manufacturing operations. The firm failed to establish and follow critical written procedures for quality control, production, equipment maintenance, and employee training. These issues indicate a systemic lack of adherence to current Good Manufacturing Practices (cGMP) regulations.

## Related Officers

- [Investigator](https://www.keypedia.com/people/saied-a-asbagh/215bfa90-995f-4310-baf3-cd9d37639b7b)

Company: https://www.keypedia.com/companies/biomylz-pvt-ltd/58a2681b-f475-4556-b06e-cd96db1b3d20

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