FDA EIR - Greenfield Global USA Inc - May 21, 2015

A pre-approval inspection was conducted by the FDA at Pharmco Products, Inc. DBA Pharmco-AAPER in Brookfield, CT, from May 19 to May 21, 2015. The inspection, carried out under CPGM 7346.832 for pre-approval inspections covering New Drug Applications (NDA) and USP standards, focused on the firm as a repacker of Active Pharmaceutical Ingredients (APIs) and industrial chemicals. The inspection revealed four significant objectionable conditions, resulting in the issuance of an FDA-483. Key issues included the company's failure to establish appropriate specifications for APIs, particularly regarding endotoxin and bioburden, suitable for products intended for use in sterile injectable drugs. Furthermore, the firm failed to implement adequate controls to prevent the distribution of products for uses beyond their stated intention, specifically after being informed that their USP-grade ethyl alcohol would be used as an API. Manufacturing deficiencies were also noted, such as the absence of filter integrity or bacterial retention tests for the final filtration step, and the filling of API in an unclassified manufacturing environment lacking suitable design to limit microbiological contaminants. Lastly, the company had not validated its cleaning operations to ensure equipment cleanliness for its intended use. In response to these findings, Pharmco-AAPER management indicated their consideration to withdraw their name from the New Drug Application, rather than implementing the extensive additional controls required to address the observations.