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.

The agency also flagged the firm’s cleaning validation procedures. The facility did not have evidence to show its in-house manufactured cleaning detergent for cleaning production equipment was effective.

Individual equipment logs were missing for certain equipment used in the manufacture of OTC drug products. For example, the firm had no equipment logbook for purified water to include when maintenance was performed. The company also did not properly label equipment with a clean/dirty status label, although the equipment was observed to be dirty.

The firm lacked records confirming laboratory equipment was calibrated prior to use, such as pH meters, balances and viscometers. pH buffers were found to be expired and reference standard weights used to calibrate balances were not appropriate to the actual amounts weighed. The reference standard weights had no certificates of calibration and were not NIST certified.