# FDA 483 - Apitoria Pharma Private Limited - May 19, 2023

Source: https://www.keypedia.com/records/483/apitoria-pharma-private-limited/38af609e-8879-4c0f-80c9-c894629e447d

> FDA 483 for Apitoria Pharma Private Limited on May 19, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apitoria Pharma Private Limited
- Inspection Date: 2023-05-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Aurobindo Pharma Limited, Unit XIV, an API manufacturer in Anakapalli District, India, revealed significant deficiencies. Observations included inadequate manufacturing equipment cleaning and storage, improper resealing of API product drums, and raw materials stored outside specified conditions. Additionally, laboratory controls were found lacking, with issues in instrument verification, secondary standard qualification, and chromatographic test precision.

## Related Officers

- [Investigator](https://www.keypedia.com/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)
- [FDA_PERSONNEL](https://www.keypedia.com/people/javier-vega/edd090c9-d867-4768-ac6a-6da459596d10)

Company: https://www.keypedia.com/companies/apitoria-pharma-private-limited/2159759f-d5e0-45cb-b80a-98f263b7f763

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