# FDA 483 - GPT Pharmaceuticals Private Ltd - January 27, 2023

Source: https://www.keypedia.com/records/483/gpt-pharmaceuticals-private-ltd/5a0b5e25-5295-425b-b14f-622759de75b9

> FDA 483 for GPT Pharmaceuticals Private Ltd on January 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GPT Pharmaceuticals Private Ltd
- Inspection Date: 2023-01-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of GPT Pharmaceuticals Private Ltd. in Hyderabad, India, revealed two significant observations. The firm failed to exercise appropriate controls over computer systems, leading to data integrity concerns with audit trails and user access. Additionally, the company's laboratory controls were found to be inadequate, specifically regarding microbiological contamination testing and cleaning validation for drug products and intermediates.

## Related Documents

- [483 - 2019-06-24](https://www.keypedia.com/records/483/gpt-pharmaceuticals-private-ltd/5444b3bd-6b98-4254-b53b-6920c9d64ea7)
- [WARNING_LETTER - 2019-06-28](https://www.keypedia.com/records/warning_letter/gpt-pharmaceuticals-private-ltd/fc35dc3f-5ad2-4f98-831a-28c7cc7d1224)

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)
- [Regulatory Officer ](https://www.keypedia.com/people/jill-tillman/4fd81eed-0de2-468b-a776-d4809fa91553)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8