# FDA 483 - Kenvue Brands LLC - April 30, 2010

Source: https://www.keypedia.com/records/483/kenvue-brands-llc/42ed78f9-1d88-4100-afb8-989db2dfbea7

> FDA 483 for Kenvue Brands LLC on April 30, 2010. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kenvue Brands LLC
- Inspection Date: 2010-04-30
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA Form 483 document details numerous violations at the Fort Washington facility, primarily concerning quality control, production, and laboratory procedures.

**Facility and Operation Details:** The inspection covers the Fort Washington facility, manufacturing Children's and Infant's Tylenol drug products, including Dye-Free Tylenol Suspension Drops.

**Violations and Observations:**
*   **Quality Control Unit Deficiencies (Observation 1):** The Quality Control Unit (QA) failed to reject raw materials with known gram-negative organism contamination, approving them for use in Tylenol products. QA and Compliance departments lacked adequate laboratory facilities, neglected validation protocol review, and were deficient in complaint follow-up, tracking, and trending.
*   **Lack of Written Procedures for Production and Process Controls (Observation 2):** No written procedures existed to ensure drug product identity, strength, quality, and purity. Specifically, process validation for Infant's Dye-Free Tylenol Drops was absent, and compounding/transfer processes were not in a "state of control" after batch size changes.
*   **Inadequate Mixing Control (Observation 3):** Control procedures did not ensure adequate mixing for uniformity and homogeneity.
*   **Failure to Monitor Manufacturing Processes (Observation 4):** Control procedures did not validate manufacturing processes causing variability, such as agitation speeds and times, leading to super potent batches.
*   **Non-Adherence to Production and Process Control Procedures (Observation

## Related Documents

- [483 - 2010-12-09](https://www.keypedia.com/records/483/kenvue-brands-llc/86bbc205-1aa4-44a7-8fc2-584c461051a6)
- [483 - 2008-02-19](https://www.keypedia.com/records/483/kenvue-brands-llc/75f3dda3-8f15-4013-b0ec-00288ce22f84)
- [483 - 2004-06-07](https://www.keypedia.com/records/483/kenvue-brands-llc/489c0539-f08e-47e8-9c0f-5b83c135fab4)
- [483 - 2010-04-30](https://www.keypedia.com/records/483/kenvue-brands-llc/a990f569-9964-4dd6-873b-3d5f9982da7d)
- [483 - 2006-01-12](https://www.keypedia.com/records/483/kenvue-brands-llc/17175522-f47b-4058-92b7-5621812a5149)

## Related Officers

- [Burns & McDonnell](https://www.keypedia.com/people/matthew-r-noonan/80e87a00-12ce-46ef-899b-cb542fe49d15)
- [Investigator](https://www.keypedia.com/people/anita-r-michael/b7699b1a-4157-477e-8226-2cfc906fc61d)
- [sharon.thoma@fda.gov](https://www.keypedia.com/people/sharon-k-thoma/d72ee980-45a4-4f2c-9b1e-e29798492e7d)
- [Hala L. Wajahat](https://www.keypedia.com/people/hala-l-wajahat/fef3b982-6593-4ebb-ab30-4277f6f25420)

Company: https://www.keypedia.com/companies/kenvue-brands-llc/69c27fd1-bbb9-4c3a-bbb5-4ac86be8e574

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