Onkos Surgical, Inc. – FDA 483, Aug 25, 2017

During an FDA inspection conducted from August 7-25, 2017, Safecross First Aid Corp., a drug manufacturer based in Newburgh, NY, received a Form FDA 483 outlining significant observations of objectionable conditions. The inspection revealed numerous deficiencies related to the firm’s adherence to Current Good Manufacturing Practices for its Over-the-Counter (OTC) drug products, including burn creams and sting relief.

Key issues included a widespread lack of established and followed written procedures. Specifically, the company failed to implement proper protocols for equipment cleaning and maintenance, premises cleaning, and comprehensive stability testing programs for its drug products, many of which were repeat observations from prior inspections in 2012 and 2014. Furthermore, there was no written program to prevent objectionable microorganisms in non-sterile drugs, with the water system remaining unvalidated and drug products not being tested.

The Quality Control unit lacked written procedures for essential functions such as complaint handling, record review, and material release. Significant gaps were noted in laboratory controls, as the firm had not established scientific specifications or test procedures for raw materials, in-process materials, or finished drug products, relying solely on supplier certificates of analysis without independent identity testing. Additionally, batch production records were incomplete, process validation had not been conducted, and employees lacked formal training in manufacturing practices. Safecross First Aid Corp. is required to address these systemic issues to ensure the quality, safety, and efficacy of its drug products and achieve regulatory compliance.