# FDA 483 - Johnson & Johnson Consumer, Inc - July 09, 2010

Source: https://www.globalkeysolutions.net/records/483/johnson-johnson-consumer-inc/a71f61fa-c407-4ccd-99d2-2e3c6a8f7fc1

> FDA 483 for Johnson & Johnson Consumer, Inc on July 09, 2010. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Johnson & Johnson Consumer, Inc
- Inspection Date: 2010-07-09
- Product Type: Drugs
- Office Name: Philadelphia District Office
- Summary: The FDA Form 483 details observations from an inspection, primarily concerning the availability of records and adherence to quality system procedures.

**Key Observations:**

*   **Record Availability:** Numerous records were not readily available upon request, including:
    *   Complete lists of rejected product batches (finished, internal, external bulk).
    *   Identification of new and discontinued products (discontinued products were delayed).
    *   Product codes.
    *   Organizational charts (delayed).
    *   Last two Annual Reports for NDA products (delayed).
    *   Summary reports for Annual Product Reviews (APR) for specific products (Pepcid Complete, Imodium Advance Caplets, water testing).
    *   Complete list of CAPAs (missing those from the old computer system).
    *   Complete list of deviations, QNs, and non-conformances (delayed).
    *   Validation Test Method for dissolution assay mobile phase mixing (delayed).
    *   Test method transfer and analyst qualification for Imodium EZ Chew dissolution assay (delayed).
    *   Filter qualification for Flow Filter used in Imodium EZ Chewable Tablets dissolution sampling (delayed).
    *   Maintenance logs for HPLC and dissolution apparatus (electronic but inaccessible).
    *   Performance qualification, calibration, and NIST traceability for Walk-In Stability Chamber (25/60).
    *   Operational manual for stability chamber maintenance and preventive maintenance (stability information unorganized

## Related Documents

- [483 - 2015-03-27](https://www.globalkeysolutions.net/records/483/johnson-johnson-consumer-inc/81d77ebc-c0b8-422e-aab8-46cef7e04b69)
- [483 - 2021-03-24](https://www.globalkeysolutions.net/records/483/johnson-johnson-consumer-inc/451e3a89-7423-4e12-b139-81b82b0bf727)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/anita-r-michael/b7699b1a-4157-477e-8226-2cfc906fc61d)
- [sharon.thoma@fda.gov](https://www.globalkeysolutions.net/people/sharon-k-thoma/d72ee980-45a4-4f2c-9b1e-e29798492e7d)

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