# FDA 483 - GPT Pharmaceuticals Private Ltd - June 24, 2019

Source: https://www.keypedia.com/records/483/gpt-pharmaceuticals-private-ltd/5444b3bd-6b98-4254-b53b-6920c9d64ea7

> FDA 483 for GPT Pharmaceuticals Private Ltd on June 24, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GPT Pharmaceuticals Private Ltd
- Inspection Date: 2019-06-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: GPT Pharmaceuticals Pvt. Ltd. in Hyderabad, India, was inspected by the FDA from June 24-28, 2019, and received a Form 483 with 10 observations. The inspection revealed significant deficiencies across quality control, laboratory operations, and manufacturing processes, including inadequate OOS investigations, data integrity issues, unvalidated test methods, and poor equipment cleaning. These issues indicate a systemic failure to adhere to cGMP requirements, raising concerns about the quality and purity of drug products.

## Related Documents

- [WARNING_LETTER - 2019-06-28](https://www.keypedia.com/records/warning_letter/gpt-pharmaceuticals-private-ltd/fc35dc3f-5ad2-4f98-831a-28c7cc7d1224)
- [483 - 2023-01-27](https://www.keypedia.com/records/483/gpt-pharmaceuticals-private-ltd/5a0b5e25-5295-425b-b14f-622759de75b9)

## Related Officers

- [Pratik S. Upadhyay](https://www.keypedia.com/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)
- [Professor](https://www.keypedia.com/people/liming-zhang/6c93b721-8725-4d87-8a42-254f3de5e49d)

Company: https://www.keypedia.com/companies/gpt-pharmaceuticals-private-ltd/e809d1f5-7f6f-4a11-99d7-ce89f08e1cf3

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