# FDA 483 - Dhaliwal Labs North, LLC - May 09, 2025

Source: https://www.keypedia.com/records/483/dhaliwal-labs-north-llc/95ac0f08-62fb-45b9-be8a-67bf5021d655

> FDA 483 for Dhaliwal Labs North, LLC on May 09, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dhaliwal Labs North, LLC
- Inspection Date: 2025-05-09
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Dhaliwal Labs North, LLC, an OTC drug manufacturer in Bedford Park, IL, was cited for significant deficiencies during an FDA inspection. Observations included inadequate qualification of their water system, a lack of essential microbiology method suitability studies and Burkholderia cepacia complex testing, and a failure to follow change control procedures for equipment. These issues indicate a lack of robust production, laboratory, and quality control processes.

## Related Officers

- [investigator](https://www.keypedia.com/people/nicholas-p-diorio/fba94f6f-38b9-4d30-b8a1-d6c9d4769e49)

Company: https://www.keypedia.com/companies/dhaliwal-labs-north-llc/3fde3718-765f-449e-8d0e-5aa71befa9e4

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669