# FDA 483 - Resonance Laboratories Private Limited - February 07, 2025

Source: https://www.keypedia.com/records/483/resonance-laboratories-private-limited/82f789b8-a570-42f4-84fa-43cbf928108e

> FDA 483 for Resonance Laboratories Private Limited on February 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Resonance Laboratories Private Limited
- Inspection Date: 2025-02-07
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Resonance Laboratories Private Limited in Bengaluru, India, an API manufacturer, revealed significant deficiencies across multiple areas. Observations included inadequate cleaning and sanitization procedures, incomplete batch production records, and insufficient process validation. Additionally, the firm was cited for unvalidated analytical methods, deficient drug substance specifications, and a lack of appropriate personnel training.

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)

Company: https://www.keypedia.com/companies/resonance-laboratories-private-limited/234ff2a1-dc68-4ea1-a3bb-fe1d29fab803

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