# FDA 483 - Dhaliwal Laboratories LLC - June 26, 2025

Source: https://www.globalkeysolutions.net/records/483/dhaliwal-laboratories-llc/b44c6538-12d6-4b34-a44c-3b7a79d8b073

> FDA 483 for Dhaliwal Laboratories LLC on June 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dhaliwal Laboratories LLC
- Inspection Date: 2025-06-26
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Dhaliwal Labs South LLC, a manufacturer in Dallas, TX, was inspected and cited for significant deficiencies in its quality control and production processes. Observations included a failure to fully qualify stability chambers for OTC drug products, a lack of proper change control for new equipment, and inadequate equipment cleaning and use logs for its filling line. These issues indicate a lack of adherence to established procedures and controls.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kevin-t-nguyen/5ae9d562-7e4f-4305-895a-4b39c35acd16)
- [Margaret M. Annes](https://www.globalkeysolutions.net/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.globalkeysolutions.net/companies/dhaliwal-laboratories-llc/62f0d6f3-3e11-47fd-b7dc-bcc656081662

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9