The US Food and Drug Administration (FDA) is warning healthcare professionals that they should stop using Monsel’s Solution (ferric subsulfate 20 percent) manufactured by California-based BioDiagnostic International over concerns that the product could be contaminated. The drug product – which is used to stop vaginal bleeding after a cervical biopsy – has been recalled by the regulator, however its distributer, MedGyn Products, has reportedly not yet contacted the medical centers which purchased the solution.
Representatives from BioDiagnostic International and MedGyn Products did not respond to Xtalks requests for a comment on the recall.
During the FDA inspection of BioDiagnostic’s Brea, California facility, which took place between January 31 to February 27, 2018, the agency noted a number of alarming current good manufacturing practice (CGMP) violations. Among these infractions was the finding that BioDiagnostic had a food preparation area that is not at all separated from the manufacturing equipment, and the facility was open to the outdoors, significantly increasing the risk of product contamination.
“You manufacture a drug product intended for vaginal use as a hemostatic solution to stop bleeding after cervical biopsies,” said the FDA warning letter. “During the inspection, our investigator observed filthy conditions in your facility, including dirty equipment and utensils covered with unknown residue. A large metal roll-up door at the entrance to your facility was open to the outdoors, while an open pot you use as a mixing vessel contained in-process material and was not covered. The insanitary conditions observed at your facility failed to protect drug products from contamination with filth.”
In addition, the firm failed to test each drug product batch for microbial and chemical quality, perhaps because the company lacks a quality control unit altogether. In addition, FDA inspectors found that “kitchen cooking pots and household power tools” were being used to manufacture Monsel’s Solution, a major violation of CGMP.
Monsel’s Solution is sold by MedGyn in a carton which contains a dozen 8ml vials of the drug along with 12 applicators. Healthcare professionals are being urged to check their supply of the solution and refrain from administering it to patients if it was distributed by MedGyn.
For its part, BioDiagnostic has issued a response to the FDA’s concerns, however the regulator was less than impressed with many of their proposed changes. For example, BioDiagnostic suggested that hiring a professional cleaning crew might solve their sanitation problem, however the FDA rebutted that increased cleaning would do nothing to fix the problems with the way their manufacturing facility is currently organized. They’re now requiring the drugmaker to submit a plan for a complete redesign of their facility to get it up to code.
“Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements,” said the warning letter. “We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance, and evaluate the completion and effectiveness of any corrective actions and preventive actions you have implemented.”
While no adverse events associated with the solution have been reported, the FDA isn’t taking any chances considering the conditions under which the product was being manufactured. The agency is also advising that patients who have recently undergone this procedure and may have been given Monsel’s Solution should speak to their doctor about their concerns.