FDA EIR - Graxcell Pharmaceutical Llc - February 17, 2017

An initial FDA inspection of Graxcell Pharmaceutical Llc, a labeler and distributor of Over-The-Counter (OTC) oral solid dosage pharmaceutical products, was conducted from February 15 to February 17, 2017. The inspection assessed the company's operations in Bohemia, NY, under the regulatory framework for drug distributors. Investigators observed a minor administrative discrepancy regarding the legal spelling of the firm's president's name on official documents, which was addressed by issuing a revised FDA Notice of Inspection (FDA 482). The primary operational observation, conveyed verbally, concerned the absence of effective dates on the firm's signed Standard Operating Procedures (SOPs). However, given Graxcell Pharmaceutical Llc's limited operational history and minimal product distribution at the time of inspection, this deficiency was communicated as a verbal observation and did not result in a formal citation on an FDA Form 483 (Inspectional Observations). Consequently, no formal violations requiring documented corrective actions were issued during this inspection. The report also noted the company's future plans to establish a separate facility for drug manufacturing, which will require new registration.