# FDA 483 - Johnson & Johnson Consumer, Inc - March 24, 2021

Source: https://www.keypedia.com/records/483/johnson-johnson-consumer-inc/451e3a89-7423-4e12-b139-81b82b0bf727

> FDA 483 for Johnson & Johnson Consumer, Inc on March 24, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Johnson & Johnson Consumer, Inc
- Inspection Date: 2021-03-24
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Johnson & Johnson Consumer, Inc. in Lancaster, PA, a drug manufacturer, was cited for failing to thoroughly review batch failures and their components. Specifically, the firm's investigation reports for Imodium Multi-Symptom Relief tablet compression and yield deviations were inadequate in assessing root causes and implementing effective corrective and preventative actions. This indicates a significant lapse in quality control and investigation processes.

## Related Documents

- [483 - 2015-03-27](https://www.keypedia.com/records/483/johnson-johnson-consumer-inc/81d77ebc-c0b8-422e-aab8-46cef7e04b69)
- [483 - 2010-07-09](https://www.keypedia.com/records/483/johnson-johnson-consumer-inc/a71f61fa-c407-4ccd-99d2-2e3c6a8f7fc1)

## Related Officers

- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)
- [Michele Gottshall](https://www.keypedia.com/people/michele-gottshall/f12dcaf7-8958-4591-88bb-f9746796b934)

Company: https://www.keypedia.com/companies/johnson-johnson-consumer-inc/2fcb5169-5a22-40c6-a782-e12c5ff16d27

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