Several weeks ago, US regulators announced that supposedly sterile products manufactured by a Tennessee compounding pharmacy were contaminated with fungus and bacteria, leading to a recall of the company's products and raising troubling parallels between the case and another one that killed dozens and left hundreds seriously injured. Now the US Food and Drug Administration (FDA) has released the details of its inspection of that compounders' facility, revealing disturbing clues into how the company's products came to be contaminated.
Spiders, Motor Oil and Splatter
The letter, known as a Form FDA-483, is regularly sent to companies to explain any deficient findings uncovered during the course of an inspection. If the findings are not sufficiently corrected, the findings can also form the basis of a Warning Letter, which details preliminary and other pending agency actions against the firm.
In the case of Tennessee-based Main Street Family Pharmacy, FDA inspectors found a motley mélange of deficiencies that ranged from the serious to the curious.
For example, the company allegedly kept no records of equipment cleaning, maintenance or use, making it impossible for investigators to determine where a particular lot of product was manufactured inside the facility. Neither could investigators determine whether endotoxin testing had actually been conducted on finished product lots.
The company's clean rooms are also anything but, according to FDA's Form 483. "Product splatter" was observed in several areas, including around the hoods used to compound the drugs; products brought into the clean room were not disinfected before being placed on supposedly clean surfaces; a disinfected gown was placed on a normal coat rack outside of the room.
The clean room also had a number of unusual deficiencies, FDA alleged. For example, a motor used for the lyophilization unit was leaking oil onto a paper towel which had apparently been placed there to collect the oil. In another instance, investigators observed two spiders in the company's ISO 6 clean room.
A Laundry List of Problems
From there, FDA noted a lengthy list of other violations, including:
- Unsterile wipes used to clean the ISO 5 hoods in the clean room
- Cracked floor tiles in the clean room
- Vials intended for use with sterile injectable products were stored "open to the environment" for hours at a time when not actively being used
- Employees who were not properly covered to assure sterile manufacturing
- Some vials were overfilled by more than 25%, but the company did not investigate the discrepancy
The company did not maintain any written procedures for the product and process controls to make sure its products meet intended standards for identity, strength, quality and purity
The release of the 483 comes just weeks after FDA first announced it had found contamination in the company's products, which were nearly identical to ones that led to a massive multi-state outbreak of fungal meningitis. That outbreak has prompted legislators to consider new authorities for FDA to regulate compounding pharmacies. That legislation is currently stalled in the House, where its passage remains uncertain.
FDA 483 to Main Street Pharmacy