FDA Hits Bulk Drug Manufacturer for Cleaning Violations

June 20, 2019

The FDA cited bulk drug and dietary supplement manufacturer PLD Acquisitions following a Jan. 17-30 inspection of its Doral, Florida facility that turned up multiple equipment cleaning and maintenance issues.

The facility lacked written procedures for cleaning and maintaining manufacturing equipment, the FDA investigator found. For example, there were no written procedures for maintaining and replacing dust filter cartridges in the vacuum transfer units of bag dumping stations, which were used during product dispensing. The violation was also found in an April 2014 inspection, the agency said.

In another repeat observation, the inside and ends of a product-contact hose with stainless steel sanitary connectors had what appeared to be white-trace residues, as well as damaged white coils on its exterior. Despite these deficiencies, it was marked as clean in the clean equipment area.

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