# FDA 483 - Haleon US Holdings LLC - September 11, 2018

Source: https://www.keypedia.com/records/483/haleon-us-holdings-llc/ce31d7f1-21e2-4865-af4a-9f9fa65672c5

> FDA 483 for Haleon US Holdings LLC on September 11, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Haleon US Holdings LLC
- Inspection Date: 2018-09-11
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: GlaxoSmithKline LLC in East Durham, NY, was inspected and received a Form 483 with two observations. The inspection revealed significant deficiencies in manufacturing process validation for toothpaste formulations and a failure to follow established quality control unit procedures. These issues indicate a lack of adequate controls over critical manufacturing and quality systems.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.keypedia.com/companies/haleon-us-holdings-llc/adf0ad1b-ed79-4d72-a254-d42d5a982384

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961