# FDA 483 - Arch Pharmalabs Ltd. - September 12, 2025

Source: https://www.keypedia.com/records/483/arch-pharmalabs-ltd/29c5f104-fb22-4e8d-860f-39f3009ce95f

> FDA 483 for Arch Pharmalabs Ltd. on September 12, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arch Pharmalabs Ltd.
- Inspection Date: 2025-09-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Arch Pharmalabs Ltd. in Dombivli, Maharashtra, an API manufacturer, revealed significant deficiencies across multiple areas. Issues included inadequate environmental monitoring and alarm systems, poor facility design leading to potential contamination, incomplete batch production records, and a lack of quality unit approval for critical changes. Additionally, the suitability of testing methods was not properly verified, and raw material weighing devices lacked suitable accuracy, indicating systemic quality control and documentation failures.

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

Company: https://www.keypedia.com/companies/arch-pharmalabs-ltd/2766781c-7a1a-4718-bb0e-04fa9616a574

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