FDA 483 - Northern New England Compounding Pharmacy, LLC - September 30, 2014

An FDA Form 483 was issued to Northern New England Compounding Pharmacy, LLC, following an inspection conducted from September 17-30, 2014. The document details several critical observations regarding the firm's sterile drug production practices. Key issues included inadequate protective apparel, as personnel in ISO 5 hoods wore non-sterile gowns and other items without evaluating their impact on sterile products. Furthermore, the cleaning and disinfection procedures for aseptic processing areas were found deficient, specifically regarding the use of non-sterile disinfectants and a lack of data supporting the sporicidal efficacy of the bleach solution used. The inspection also noted failures in laboratory testing, as sterility and endotoxin testing were not required for batches of sterile drug products with fewer than 25 dosage units. Critical sterilization processes, such as the autoclave cycle for specific ophthalmic suspensions and nasal irrigations, lacked validation. Lastly, environmental monitoring was deemed insufficient, with no daily monitoring of frequently used ISO 5 hoods and a lack of defined actions when microbial contamination limits were exceeded. These observations, issued under the Federal Food, Drug, and Cosmetic Act, require the company to implement comprehensive corrective actions to address the identified non-compliances and ensure the safety and sterility of its drug products.