Two sterile compounders hit by FDA warning letters for violating cGMP

By Dan Stanton

- Last updated on GMT

Since 2013, compounders have the option to register as outsourcing facilities with the US FDA
Since 2013, compounders have the option to register as outsourcing facilities with the US FDA

Related tags Fda

The US FDA has lambasted two sterile compounders for violating cGMP in letters citing recent legislation brought in to ensure such companies are fully regulated.

The first letter was sent to Florida-based Absolute Pharmacy, a compounding pharmacy which opted to register as an outsourcing facility with the US Food and Drug Administration (FDA) after the Drug Quality and Security Act (DQSA) became law in 2013​.

“The investigator noted that drug products that were intended or expected to be sterile were prepared, packed, or held under insanitary conditions,”the letter​ dated April 27 states.

The agency noted further violations of current Good Manufacturing Practices (cGMP) including: failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas, failing to clean and sterilise containers to remove pyrogenic properties, and failing to establish an adequate air supply filtered through high-efficiency particulate air filters.

“Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA,”​ the letter continued, adding the FDA has recently issued draft guidance​ for Human Drug Compounding Outsourcing Facilities which, when finalised, will fully describe the expectations regarding such facilities.

Vann Healthcare Services

The DQSA and the continued regulatory updates surrounding compounding pharmacies were deemed necessary after a number of high profile incidents, most infamously the death of 64 patients from an outbreak of fungal meningitis in 2012​ linked to compounded drugs formulated at the New England Compounding Center (NECC) in Massachusetts.

However, the Act fell short of the FDA’s desire​ to make all compounders register as outsourcing facilities, instead it was hoped a voluntary action would occur as physicians give preference to registered suppliers.

Despite this, non-registered compounder Vann Healthcare Services has also been hit by a warning letter​, dated April 29, based on violations of the FDCA including the misbranding and adulteration of drug products made at the facility in Glasgow, Kentucky.

Additionally, the agency noted failures in following written protocols to prevent microbiological contamination of sterile drug products, failures to ensure that manufacturing personnel wear clothing appropriate to avoid contamination, and issues with cleaning and disinfecting the aseptic equipment.

“For example, the investigator observed that your operator produced sterile drug products with exposed skin on wrists and upper chest. In addition, your firm did not use a sporicidal agent to disinfect the ISO 5 area.”

The company has issued a voluntary recall of all sterile products and informed the FDA it has ceased from producing sterile drugs.

“If you decide to resume production of sterile drugs, FDA strongly recommends that your management undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, materials, and systems,”​ the Agency said.

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