# FDA 483 - Agon Pharma Private Ltd - June 13, 2019

Source: https://www.globalkeysolutions.net/records/483/agon-pharma-private-ltd/1b5b2ebd-405b-437e-a682-7fc4490d95d6

> FDA 483 for Agon Pharma Private Ltd on June 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Agon Pharma Private Ltd
- Inspection Date: 2019-06-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Agon Pharma Pvt. Ltd. in Pune, Maharashtra, India, was cited with four observations during an FDA inspection regarding significant deficiencies in their manufacturing controls. These issues included inadequate batch production records, improper identification of raw materials and in-process equipment, and a failure to follow change control procedures for facility modifications. The findings indicate a lack of adherence to established quality assurance and production control standards.

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## Related Officers

- [Kara Dobbin](https://www.globalkeysolutions.net/people/kara-dobbin/0b35e025-4389-46df-abcb-30e70693f62b)

Company: https://www.globalkeysolutions.net/companies/agon-pharma-private-ltd/2afb72ee-bf1b-40fc-80c1-a65340d97caa

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