FDA Hits Florida OTC Drugmaker for Quality Violations
OTC drug manufacturer Pharma Natural drew a lengthy Form 483 for a long list of deficiencies at its Miami Lakes, Florida facility.
The FDA investigator noted the facility lacked sound test procedures to assure the OTC products’ identity, strength, quality and purity. The firm also failed to perform process validation and stability studies for some products.
In addition, the facility’s procedures for handling product complaints lacked time frames for complaint investigations — and there was no documentation of impacted batches associated with complaints, recalls, returns and out-of-specification investigations.