# FDA 483 - Aspiro Pharma Limited - October 07, 2021

Source: https://www.globalkeysolutions.net/records/483/aspiro-pharma-limited/7916592a-8c6d-4ccc-92c1-7b022fa8a02d

> FDA 483 for Aspiro Pharma Limited on October 07, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aspiro Pharma Limited
- Inspection Date: 2021-10-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Aspiro Pharma Limited, a sterile pharmaceutical manufacturer in Siddipet, Telangana, India, received a Form 483 with repeat observations. The inspection revealed significant failures in quality control, including inadequate review of discrepancies, insufficient trending of root causes for corrective actions, and a failure to properly record and justify deviations during manufacturing. These issues indicate a systemic weakness in their quality management system.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

Company: https://www.globalkeysolutions.net/companies/aspiro-pharma-limited/3e15b7cf-74e6-4a2d-927d-49bc23284d72

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