# FDA 483 - APDM Pharmaceuticals Private Limited - June 12, 2026

Source: https://www.keypedia.com/records/483/apdm-pharmaceuticals-private-limited/9cd867e8-77cb-4ceb-9ddd-ff79169cd0e9

> FDA 483 for APDM Pharmaceuticals Private Limited on June 12, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: APDM Pharmaceuticals Private Limited
- Inspection Date: 2026-06-12
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: APDM Pharmaceuticals Private Limited in Ahmedabad, India, received a Form 483 for deficiencies related to equipment design and qualification. The firm failed to adequately qualify operating parameters for equipment used in the commercial manufacturing of drug products. Additionally, sensors on the bottle filling and capping machines were not properly challenged to detect critical errors and defects, indicating a lack of appropriate validation for manufacturing and packaging equipment.

## Related Officers

- [Investigator](https://www.keypedia.com/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)

Company: https://www.keypedia.com/companies/apdm-pharmaceuticals-private-limited/8b401ef5-91fa-48a4-a549-cfc260ef4446

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