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

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