# FDA 483 - Apitoria Pharma Private Limited - February 02, 2019

Source: https://www.globalkeysolutions.net/records/483/apitoria-pharma-private-limited/413edfc9-6cdb-41b0-851f-7ffd80aed504

> FDA 483 for Apitoria Pharma Private Limited on February 02, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apitoria Pharma Private Limited
- Inspection Date: 2019-02-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Aurobindo Pharma Ltd, Unit 9, a manufacturer of starting materials and advanced intermediates in Gundlamachanoor Village, India, revealed significant deficiencies. The firm's investigations into genotoxic impurities were inadequate, and its cleaning validation processes for non-dedicated equipment were found to be deficient. Further issues included inadequate corrective and preventive actions, unvalidated analytical methods, and failures in laboratory equipment calibration and data integrity.

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Company: https://www.globalkeysolutions.net/companies/apitoria-pharma-private-limited/7a543877-97f7-4c4a-8dc8-74ee9d1c0caf

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