# FDA 483 - Aspen Biopharma Labs Pvt., Ltd. - September 21, 2024

Source: https://www.keypedia.com/records/483/aspen-biopharma-labs-pvt-ltd/549a2e47-d3c8-431a-a7f8-70a44164ebcc

> FDA 483 for Aspen Biopharma Labs Pvt., Ltd. on September 21, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aspen Biopharma Labs Pvt., Ltd.
- Inspection Date: 2024-09-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Aspen Biopharma Labs Pvt Ltd in Rangareddy, Hyderabad, India, was cited for significant deficiencies across its API manufacturing operations. The inspection revealed severe data integrity issues, a non-functional Quality Unit, inadequate process validation, and poor facility and equipment maintenance, exacerbated by recent flood damage and ongoing renovations. These findings indicate a pervasive lack of control over critical manufacturing processes and documentation.

## Related Officers

- [Investigator](https://www.keypedia.com/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)
- [Khalid M. Khan](https://www.keypedia.com/people/khalid-m-khan/fb4bde8b-b17c-4686-b5af-e602c8a46e18)

Company: https://www.keypedia.com/companies/aspen-biopharma-labs-pvt-ltd/76a2fe2a-2b30-4a89-9e00-dac2ca28aa73

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