California OTC Drugmaker Flagged for Numerous Violations

The FDA hit Product Packaging West, an OTC drug manufacturer in Hollywood, California, with a Form 483 after an inspection revealed deficiencies with its purified water system, cleaning procedures and equipment calibration.

The inspection, which was carried out in March, found the firm failed to shut off the purified water system when it was not in use and did not address foreign substances found at the bottom of a water storage tank. The tank had an orange color around its drainage hole and a black substance surrounding the recirculation hole. Microbial samples from the system had not been tested since December 2016, and no documentation existed showing that water sanitization was performed.

In addition, the facility did not qualify its purified water system although it used the water in its OTC drug products and cleaning procedures.