Porton Biopharma, Limited, Salisbury received a Warning Letter following their most recent audit (View Link). Porton Biopharma, Limited, Salisbury, was audited from March 7-18, 2016 as a follow-up to an audit conducted January 12-23, 2015 wherein similar findings were observed. The repetition of these findings were observed to be so substantial that the FDA will contact Porton Biopharma to schedule a face-to-face regulatory meeting to ensure prompt action is taken to correct the volatile conditions found during the 2015 and 2016 inspections discussed within the Warning Letter.
- Your firm failed to establish and follow appropriate written procedures, designed to prevent microbiological contamination in drug products purporting to be sterile (21 CFR 211.113(b).
During our January 2015 inspection, our investigators observed several deficiencies related to your aseptic manufacturing operation, including the following:
- a restricted access barrier system (RABS) (b)(4) which had fallen off the enclosure system;
- a lack of environmental monitoring within the RABS;
- no use of sporicidal disinfectant on surfaces inside aseptic filling room (b)(4), although your environmental monitoring detected spore-forming organisms there; and
- a lack of traceability for media-filled vials.
We discussed these deficient manufacturing practices during a regulatory meeting with your firm on November 24, 2015.
The Observations noted during the January 2015 inspection represent significant problems for an aseptic manufacturing facility. Any one of the Observations, in and of itself, can create a situation where the FDA deems the products being produced as adulterated. Since no manufacturing was on-going during the March 2016 audit, it was impossible to assure that the deficiencies had been corrected.
During our March 2016 inspection, our investigators observed the following additional aseptic manufacturing issues:
- a floor exhaust vent, shown in smoke studies to remove air entering the filling room, blocked by ancillary equipment during media fill process simulations
- inadequate validation of the (b)(4) sterilization cycle used on equipment to be transferred into aseptic filling room (b)(4)
It is critical that your firm implement proper ongoing control over your aseptic processing operation to prevent microbial contamination of your injectable products.
Again, either or both of these Observations could again deem the products manufactured to be adulterated. The most glaring Observation, inadequate validation of the sterilization cycle, could result in equipment being microbially contaminated prior to its entering the ISO 5 environment.
We note that your firm did not conduct drug product batch manufacturing during our recent inspections. We will need to observe your manufacturing operation during the next inspection to determine whether corrective actions have been fully implemented.
It is not unusual for foreign firms to cease production in various manufacturing areas when the FDA has scheduled an audit of their facilities. These facilities need to recognize that when they do this repeatedly, the FDA will often unilaterally cite these firms as having adulterated product, issue an Import Alert and, ultimately, issue another Warning Letter. Citing that a drug product batch manufacturing area is not operational only can be viewed as a short term strategy.