# FDA 483 - Haleon US Inc. - September 30, 2021

Source: https://www.globalkeysolutions.net/records/483/haleon-us-inc/62f851a1-563f-4ffc-a4ec-eb6f8d67e1b3

> FDA 483 for Haleon US Inc. on September 30, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Haleon US Inc.
- Inspection Date: 2021-09-30
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of GSK Consumer Health Inc. in Lincoln, NE, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to thoroughly review out-of-specification materials and packaging defects, leading to distributed products with potential quality issues. Additionally, there were inadequate written procedures for the quality control unit, equipment cleaning, microbial control in water systems, and the drug product stability program.

## Related Documents

- [483 - 2011-07-08](https://www.globalkeysolutions.net/records/483/haleon-us-inc/64a8b65b-0f2c-4329-bbdc-9e75dc0aac4f)
- [483 - 2013-02-14](https://www.globalkeysolutions.net/records/483/haleon-us-inc/77ad0d4e-a7bd-460b-ba38-1a7299e89a9d)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)
- [Drug National Expert](https://www.globalkeysolutions.net/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)
- [Consumer Safety Officer/ Federal Investigator](https://www.globalkeysolutions.net/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)

Company: https://www.globalkeysolutions.net/companies/haleon-us-inc/59f65cda-88dc-4ec6-98a9-42bd852cb203

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8