# FDA 483 - Anthea Pharma Private Limited - April 04, 2025

Source: https://www.keypedia.com/records/483/anthea-pharma-private-limited/cc074a9f-6871-44da-abe4-0fe08596b9f3

> FDA 483 for Anthea Pharma Private Limited on April 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Anthea Pharma Private Limited
- Inspection Date: 2025-04-04
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Anthea Pharma Private Limited in Hyderabad, India, was inspected and cited for significant deficiencies in quality control and aseptic processing. The firm failed to reject drug products with visible particulates, lacked adequate procedures to prevent microbiological contamination, and had insufficient written procedures for production and process controls. These issues indicate a serious lack of control over drug product quality and sterility assurance.

## Related Documents

- [483 - 2024-07-05](https://www.keypedia.com/records/483/anthea-pharma-private-limited/5af83eb8-34b8-4c15-97a1-0a1677059e1f)
- [483 - 2025-12-22](https://www.keypedia.com/records/483/anthea-pharma-private-limited/07833743-7633-4159-a5a4-ef59800bdf37)

## Related Officers

- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

Company: https://www.keypedia.com/companies/anthea-pharma-private-limited/8a693110-e769-4df9-80b4-c43f814550c3

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