# FDA 483 - Senador Laboratories Private Limited - November 24, 2025

Source: https://www.keypedia.com/records/483/senador-laboratories-private-limited/8b822eef-4510-4b00-914e-6650fb19646d

> FDA 483 for Senador Laboratories Private Limited on November 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Senador Laboratories Private Limited
- Inspection Date: 2025-11-24
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Senador Laboratories Private Ltd. in Ahmedabad, India, a sterile drug manufacturer, revealed significant deficiencies across its quality system. Observations included a lack of scientifically justifiable in-process controls for visual inspection, inadequate investigations into batch failures, and multiple issues with quality control unit procedures. These issues encompass insufficient visual inspection training, unsupported sampling plans, missing qualified test methods, and poor environmental monitoring data management.

## Related Officers

- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

Company: https://www.keypedia.com/companies/senador-laboratories-private-limited/07781b9f-6d88-4334-96e4-438175fbaf9d

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