FDA Hits UK Drugmaker for CAPAs, Records

The FDA flagged deficiencies in corrective actions, testing and documentation during a July/August inspection of UK drug substance and sterile drug manufacturer Porton Biopharma.

In an inspection of Porton’s facility in Salisbury, Wiltshire, FDA investigators found inadequate corrective and preventive actions to reduce contamination with foreign materials and a failure to properly review failures of component batches to meet specifications, according to the Form 483.

In addition, the facility’s equipment and processes were not properly designed to prevent contamination of product by substances that “could reasonably be expected to have an adverse effect on product quality.” The company also failed to conduct a risk assessment for certain bulk drug substances and failed to properly document rejected media filled units, according to the FDA.