# FDA 483 - Aktinos Pharma Private Limited - Unit II - December 12, 2025

Source: https://www.keypedia.com/records/483/aktinos-pharma-private-limited-unit-ii/404b0eaf-37de-4dee-bf35-ce0d82f00e0e

> FDA 483 for Aktinos Pharma Private Limited - Unit II on December 12, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aktinos Pharma Private Limited - Unit II
- Inspection Date: 2025-12-12
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Aktinos Pharma Private Limited - Unit II, an API manufacturer in Anakapalli, India, revealed significant deficiencies in quality control and equipment maintenance. The firm's Quality Unit failed to identify out-of-specification results during batch record review, leading to the release of non-conforming intermediate batches. Additionally, manufacturing equipment was not maintained in a clean condition or good state of repair, including a cracked vessel and equipment with residue and pitting.

## Related Documents

- [483 - 2022-10-14](https://www.keypedia.com/records/483/aktinos-pharma-private-limited-unit-ii/bd161630-0e07-4070-baad-8abd93617895)

## Related Officers

- [Pharmaceutical Program Expert](https://www.keypedia.com/people/zachary-l-stamm/b729fab9-4d31-4c70-b5b3-e8b6207769c6)

Company: https://www.keypedia.com/companies/aktinos-pharma-private-limited-unit-ii/81f7ec33-4c2f-4ae8-ac13-851cbc8e1949

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