Nova-Tech Inc. – FDA EIR, Apr 22, 2016

An FDA routine Good Manufacturing Practice (GMP) inspection was conducted at Nova-Tech Inc. in Grand Island, NE, from April 18 to April 22, 2016. The inspection, which focused on the company's sterile veterinary drug manufacturing operations, was guided by Compliance Programs for Animal Drug Manufacturing and Sterile Drug Process Inspections. Investigators identified two significant objectionable conditions, leading to the issuance of an FDA Form 483. The first observation concerned the firm's laboratory controls, specifically the sampling plan and test procedures for water. Nova-Tech Inc. was cited for not demonstrating that endotoxin levels in water samples remained constant after being stored for an unspecified period prior to testing, indicating a lack of scientifically sound procedures to assure component quality. The second observation highlighted deficiencies in written production and process control procedures. The company's "Rework of Product" procedure was deemed inadequate as it failed to document the quantity of product collected during system priming or the number of containers reprocessed. Furthermore, procedures for handling bottles in the clean room when they were extruding, tilted, or fallen were not clearly defined. Management was formally advised of their responsibilities under the Federal Food, Drug, and Cosmetic Act and the potential consequences of non-compliance, including regulatory actions such as seizure, warning letters, or injunctions. Nova-Tech Inc. committed to providing a written response to the FDA Form 483 within 15 business days.