FDA Gives UK Facility Warning Letter

January 25, 2017

The agency finds repeated CGMP violations at Porton Biopharma, Limited.

On Jan. 19, 2017, FDA sent a warning letter to Porton Biopharma, Limited following an inspection performed at the company’s Manor Farm Road, Porton Down, Salisbury, UK facility from March 7–18, 2016. Inspectors found violations of current good manufacturing practices (CGMP) including failing to test batch failures and improper sterile manufacturing procedures. The agency stated in the letter that similar deviations were found during a 2015 inspection of the facility.  Additional violations were found regarding the establishment of change controls.

During the 2016 inspection, FDA investigators found that the company’s corrective action and preventive action (CAPA) plans were not adequate to investigate unexplained discrepancies or batch failures that did not meet specifications. The company, according to the agency, did not properly investigate particulate matter found by the quality unit in batches of product. Additionally, several batch records indicated contamination from multiple sources. “Your investigations indicated that these additional instances of contamination are likely from another source besides the stoppers and call into question your ability to prevent contamination,” FDA stated. “These repeated failures demonstrate that management oversight and control over the manufacture of drugs at your facility is inadequate, and that your previous corrective actions did not address persistent contamination hazards and drug quality issues.”

Investigators also discovered that the company had failed to establish appropriate written procedures to prevent microbiological contamination in sterile products. Both the 2015 and 2016 inspections found aseptic manufacturing deficiencies. In 2015, FDA found an enclosure system with a fallen restricted access barrier system (RABS); a lack of environmental monitoring in the RABS; the failure to use sporicidal disinfectants on surfaces inside the aseptic filling room; and a lack of traceability for media-filled vials.

Despite a meeting between FDA and the company in November 2015, inspectors found additional aseptic manufacturing issues including a blocked floor exhaust vent and inadequate validation of sterilization cycles used on equipment. “It is critical that your firm implement proper ongoing control over your aseptic processing operation to prevent microbial contamination of your injectable products,” FDA stated. 

The agency stressed the company’s responsibility in ensuring quality in its products. “You are responsible for investigating these violations and deviations, for determining the causes, for preventing their recurrence, and for preventing other violations and deviations … You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act [Food, Drug, and Cosmetic Act] to ensure safety, identity, strength, quality, and purity,” FDA stated in the letter.

Source: FDA