FDA EIR - LNK International, Inc. - February 08, 2019

An FDA surveillance inspection of LNK International, Inc., an OTC drug manufacturer in Hauppauge, NY, was conducted from January 23 to February 8, 2019, under the Current Good Manufacturing Practices (cGMP) regulatory framework. The inspection revealed three significant observations. Firstly, the company failed to thoroughly review and reject drug product batches with confirmed out-of-specification (OOS) microbial contamination. Specifically, several lots of Diphenhydramine 50 mg Berry Syrup, with OOS microbial counts, were released based on retesting for preservative effectiveness, contrary to the firm's own procedures that mandate rejection of OOS lots. Secondly, investigations into drug product complaints, particularly regarding 'ineffective' combination solid oral dosage products (Acetaminophen-Diphenhydramine HCl and Acetaminophen-Phenylephrine HCl), were inadequate. These investigations did not include a review of crucial testing methods like dissolution or bioavailability studies, which were not performed for these products. Finally, laboratory controls were found lacking, as various combination solid oral dosage drug products containing Acetaminophen were not routinely tested for known impurities, such as 4-Aminophenol, or for dissolution during release and stability studies. In response, management committed to destroying one affected OOS microbial lot that had not yet been distributed, but opted to monitor already-distributed OOS lots on stability rather than initiate a recall. They also pledged to revise testing procedures to incorporate dissolution testing for solid oral dosage products and to conduct a comprehensive analysis of product lines lacking appropriate impurity and dissolution test methods.