ISSUE: SEPTEMBER 2013 | VOLUME: FDA Reasserts Concerns About NuVision Sterile Products by George Ochoa

The FDA continued to advise health care providers not to use sterile products from NuVision Pharmacy of Dallas, because the sterility of the products is not assured, according to an Aug. 16 FDA news release. This alert followed an April recall by NuVision of methylcobalamin injection and lyophilized injection products due to a lack of sterility assurance, and a May 18 FDA announcement of expanded concerns about a lack of sterility assurance of all NuVision’s sterile drug products.

“The FDA received adverse event reports of fever, flu-like symptoms, and soreness at the injection site associated with the methylcobalamin injection product” that was recalled, said the Aug. 16 news release.

NuVision has repeatedly declined FDA requests for a more widespread recall of the company’s sterile products, according to the agency; the FDA said it lacks the authority to require such a recall. Most recently, on July 26, the FDA issued a letter to NuVision outlining poor sterile production practices observed during an FDA inspection of NuVision’s Dallas facility. Among the agency’s findings:

• The firm’s facility design “was inadequate for the processing of aseptically filled, injectable products.” HEPA filters, for example, “covered less than one-half of the area in which sterile drugs are aseptically manipulated.”
• The ISO area where the HEPA filters were located “consisted of a table with inadequate protection to safeguard the sterile product from influx of lower-quality air from the immediately adjacent ISO 7 clean room.” Without an adequate physical barrier, the FDA’s letter noted, the compounding area was vulnerable to microbial contamination from the activities of personnel in or near the work area.
• The company lacked any proof that the aseptic work area “was supplied with a clean unidirectional air of sufficient velocity to protect sterile components from microbial contamination during aseptic processing.”

The letter, from Melinda K. Plaisier, the acting associate commissioner for regulatory affairs at the FDA, requested an immediate “recall of all lots of all sterile products produced at NuVision that are within expiry,” and warned, “if a drug product marketed as sterile contains microbial contamination, patients could be at risk for serious infections, which may be life-threatening.” NuVision responded by refusing the requested recall, according to the Aug. 16 news release.

On NuVision’s website, the company stated that it is not recalling all sterile injectables, and that all its sterile injectables are tested for sterility by a third-party laboratory before dispensing. The website also reports that NuVision is a compounding pharmacy, not a manufacturer. “We are in compliance with USP [Chapter] <795> and [Chapter] <797> which are the standards of law for compounding pharmacy. The FDA has been inspecting compounding pharmacies based on a different set of standards for manufacturers called FDA 210 and 211. … The current state laws do not require compounding pharmacies to follow the standards for manufacturing.”

The FDA advises health care professionals to check their medical supplies for NuVision sterile products, quarantine any such products, and not administer them to patients.

quoted from here