# FDA 483 - Haleon US Inc. - July 08, 2011

Source: https://www.keypedia.com/records/483/haleon-us-inc/64a8b65b-0f2c-4329-bbdc-9e75dc0aac4f

> FDA 483 for Haleon US Inc. on July 08, 2011. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Haleon US Inc.
- Inspection Date: 2011-07-08
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 document details numerous violations and deficiencies observed during an inspection of a drug product manufacturing and packaging facility. The facility, identified as NCH-Lincoln, manufactures and packages various drug products, including Excedrin, Bufferin, and No Doz, as well as DEA schedule products.

**Key Violations and Observations:**

*   **Quality Control Unit Failures (Observation 1):** The Quality Unit (QU) failed to adequately monitor Quality Systems, evidenced by recurring issues, NDA Field Alerts, and recalls for similar problems over several years.
*   **Inadequate Investigations (Observations 2, 3, 7, 8):**
    *   Failure to open deviation investigations for numerous "critical" consumer complaints of foreign products found in drug products.
    *   Investigations did not extend to all potentially affected batches of product. Examples include mix-up complaints for Excedrin Migraine Tablets/Caplets and Excedrin Extra Strength Caplets/Gelcaps. This is a repeat deficiency from a previous inspection.
    *   Failure to identify the root cause of customer complaints for solid dosage form foreign tablets since at least 2009, despite continued evidence of mix-ups. Conclusions drawn in investigations were often not supported by evidence.
*   **Failure to File NDA Field Alerts (Observation 4):** The firm failed to submit NDA Field Alerts within three working days of identifying incidents where a drug product or

## Related Documents

- [483 - 2013-02-14](https://www.keypedia.com/records/483/haleon-us-inc/77ad0d4e-a7bd-460b-ba38-1a7299e89a9d)
- [483 - 2021-09-30](https://www.keypedia.com/records/483/haleon-us-inc/62f851a1-563f-4ffc-a4ec-eb6f8d67e1b3)

## Related Officers

- [Eric Mueller](https://www.keypedia.com/people/eric-mueller/c2da0580-e8b7-41d8-94b6-3579d2bfad8b)
- [Compliance Officer, CDER, Office of Manufacturing](https://www.keypedia.com/people/joseph-r-lambert/d2968fda-8e5e-433a-b60b-f68aaef3b7b0)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c