# FDA 483 - Johnson & Johnson Consumer, Inc - March 27, 2015

Source: https://www.globalkeysolutions.net/records/483/johnson-johnson-consumer-inc/81d77ebc-c0b8-422e-aab8-46cef7e04b69

> FDA 483 for Johnson & Johnson Consumer, Inc on March 27, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Johnson & Johnson Consumer, Inc
- Inspection Date: 2015-03-27
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: McNeil Consumer Pharmaceutical Products in Lancaster, PA, was inspected and cited for significant deficiencies in its manufacturing process controls and quality control unit authority. Observations included a lack of scientific rationale for compression speed ranges and failure to investigate out-of-range batches for Imodium, alongside the destruction of rejected product batches prior to the completion of deviation investigations. These issues indicate a serious breakdown in ensuring product quality and proper handling of non-conforming materials.

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## Related Officers

- [Rabin N. Ghoshal, Chemist](https://www.globalkeysolutions.net/people/rabin-n-ghoshal-chemist/d6645223-978a-4a85-8701-088d2ed466be)
- [Thomas E. Friel, Investigator](https://www.globalkeysolutions.net/people/thomas-e-friel-investigator/4a7a2cc4-627a-434c-852f-889181984c12)
- [James M. Mason, Investigator](https://www.globalkeysolutions.net/people/james-m-mason-investigator/e8dd50ad-8336-4328-a0cf-e5199f5d28cc)

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

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