# FDA 483 - Kenvue Brands LLC - July 07, 2017

Source: https://www.keypedia.com/records/483/kenvue-brands-llc/362b647d-b802-4ff1-9e8a-aea8e15a108a

> FDA 483 for Kenvue Brands LLC on July 07, 2017. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Kenvue Brands LLC
- Inspection Date: 2017-07-07
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: During an inspection, Johnson & Johnson Consumer Inc. in Lititz, PA, was cited for failing to reject drug products that did not meet established standards and specifications. Specifically, an active pharmaceutical ingredient (API) with an out-of-specification (OOS) assay result was released into production. This OOS material was subsequently used to manufacture finished Listerine Naturals Antiseptic batches.

## Related Officers

- [Investigator](https://www.keypedia.com/people/anita-r-michael/b7699b1a-4157-477e-8226-2cfc906fc61d)

Company: https://www.keypedia.com/companies/kenvue-brands-llc/2f06d979-d58e-4f22-9975-eba786e0bed7

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8