FDA EIR - Generics Bidco II LLC - March 11, 2020

A routine comprehensive FDA inspection of Generics Bidco II LLC d/b/a Prinston Laboratories, a non-sterile solid dose human drug manufacturer in Charlotte, NC, was conducted from March 9-11, 2020. The inspection, performed in accordance with Compliance Policy Guidance Manual 7356.002 (Drug Manufacturing Inspections), focused on the Quality, Materials, Production, and Packaging and Labeling Systems. No Form FDA 483 Inspectional Observations were issued at the conclusion of this inspection, indicating that no significant new violations were identified.

The document highlights that the firm had voluntarily corrected all previous verbal observations discussed during a June 2019 inspection. These included issues related to gas chromatograph calibration, water system documentation, identification of rooms and warehouse racks, pump calibration documentation, updating the material transportation SOP, and managing warehouse material capacity. These corrections were verified during the March 2020 inspection.

The review covered various records, including non-conformances, annual reports, batch records, and investigations for products such as Hydro/APAP and Cyclobenzaprine. Management was reminded of its responsibility to adhere to the Food, Drug, and Cosmetic Act. No new objectionable conditions were noted, and no specific new actions were required from the firm following this inspection.