FDA EIR - Noramco, Inc. - February 21, 2019

An FDA inspection of Noramco, Inc.'s manufacturing facility in Wilmington, DE, was conducted from February 19-21, 2019. This was a limited inspection under the CDER Opioid Quality Survey Part 1, aimed at collecting samples of opioid active pharmaceutical ingredients (APIs) to assess the supply chain for potential quality risks or economically motivated adulteration. The regulatory framework for this visit focused on sample collection rather than a comprehensive good manufacturing practice (GMP) review.

During this specific inspection, no new violations were observed, and therefore, no Form FDA-483 (List of Inspectional Observations) was issued to management. The inspection concluded with the collection of four opioid API samples: Hydrocodone Bitartrate, Hydromorphone Hydrochloride, Morphine Sulfate, and Buprenorphine Hydrochloride.

However, the report referenced a previous routine surveillance CGMP inspection in November 2017, where Noramco, Inc. received a two-item Form FDA-483. These previous observations noted deficiencies in following quality unit responsibilities and procedures, and a lack of established procedures for lot distribution traceability to facilitate recalls. While these prior issues were classified as "Voluntary Action Indicated" and the firm committed to a written response, their corrections were not assessed during the current sample-collection focused inspection. No new required actions were mandated from the February 2019 inspection.