# FDA 483 - Ajanta Pharma Ltd. - June 28, 2019

Source: https://www.globalkeysolutions.net/records/483/ajanta-pharma-ltd/15e08bf4-14a3-4a50-a9be-2ac0598f15bb

> FDA 483 for Ajanta Pharma Ltd. on June 28, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ajanta Pharma Ltd.
- Inspection Date: 2019-06-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Ajanta Pharma Ltd. in Aurangabad, Maharashtra, India, was cited for five observations during an FDA inspection from June 24-28, 2019. The inspection revealed significant deficiencies in computer system controls, laboratory controls including microbiological testing and instrument calibration, quality control unit responsibilities, and equipment design for an inspection and sorting machine. These issues indicate a lack of appropriate controls and procedures to ensure drug product quality and purity.

## Related Officers

- [Jose A. Lopez-Robles](https://www.globalkeysolutions.net/people/jose-a-lopez-robles/73ed16a0-3b6f-414b-938f-e58b027c3e9b)
- [Investigator ](https://www.globalkeysolutions.net/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

Company: https://www.globalkeysolutions.net/companies/ajanta-pharma-ltd/040efb87-46b2-4747-b87d-c1d87daad1e7

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