# FDA 483 - Dhaliwal Pharmaceuticals Laboratories, LLC - March 01, 2022

Source: https://www.globalkeysolutions.net/records/483/dhaliwal-pharmaceuticals-laboratories-llc/966efe70-32ac-40c8-8ed4-e9f8a2f9337b

> FDA 483 for Dhaliwal Pharmaceuticals Laboratories, LLC on March 01, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dhaliwal Pharmaceuticals Laboratories, LLC
- Inspection Date: 2022-03-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Dhaliwal Pharmaceuticals Laboratories, LLC, an OTC drug manufacturer in Mesquite, TX, was cited for failing to follow written production and process control procedures. Specifically, the firm had not completed process validation studies for an OTC topical drug product, leading to the release of unvalidated batches. This indicates a significant lapse in quality control and adherence to manufacturing standards.

## Related Officers

- [Michelle A. Krayer](https://www.globalkeysolutions.net/people/michelle-a-krayer/c68b88a6-d3d3-4407-867b-81b92b7ce977)

Company: https://www.globalkeysolutions.net/companies/dhaliwal-pharmaceuticals-laboratories-llc/6b73fbe1-22b4-4f57-a4f9-74246f77b9b9

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab