# FDA 483 - Mayon's Pharmaceuticals Private Ltd - February 20, 2020

Source: https://www.keypedia.com/records/483/mayons-pharmaceuticals-private-ltd/22846053-3895-4bca-ab2a-5a01c0a5d397

> FDA 483 for Mayon's Pharmaceuticals Private Ltd on February 20, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mayon's Pharmaceuticals Private Ltd
- Inspection Date: 2020-02-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Mayon's Pharmaceuticals Pvt Ltd, a homeopathic drug manufacturer in Nagpur, India, was cited with eight observations during an FDA inspection from February 11-20, 2020. The inspection revealed significant deficiencies across quality control, production and process controls, equipment design and maintenance, and record-keeping. Key issues include inadequate product testing, incomplete batch records, lack of process validation, and insufficient microbial control procedures.

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/andrew-k-haack/d0e236ac-3223-43e0-8378-300de21b19f5)

Company: https://www.keypedia.com/companies/mayons-pharmaceuticals-private-ltd/f9a14533-98a7-4bd8-8578-37b81ff2c2af

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