FDA issued warning letters to drug and medical device
manufacturers for violations of CGMP ("Current Good
Manufacturing Practices"), QSR ("Quality Systems
Regulations"), and MDR ("Medical Device Reporting")
requirements. In addition, two compounding pharmacies were recently
cited for insanitary conditions, including operators using
nonsterile gowns and nonsterile facemasks, and for distributing
products without proper labels. Both companies were registered as
outsourcing facilities under Section 503B of the federal Food, Drug
& Cosmetic Act, which requires compliance with certain CGMP
provisions.
The agency warned a pharmaceutical manufacturer for CGMP
violations, including deficient aseptic and sterilization
processes. Demonstrating a continued focus on security, FDA also
warned the manufacturer for not having adequate controls to prevent
unauthorized access to computer systems and laboratory data.
FDA warned a manufacturer of spirometers and a company that
produces knee-replacement devices for several violations, including
failures to establish and maintain corrective and preventative
actions ("CAPAs"), deficiencies in their complaint
handling and MDR processes, and inadequate controls for design
validation. Additionally, a contact lens company was cited for not
responding to FDA 483 Inspectional Observations, which included
failing to implement CAPAs, establish training procedures, and
adequately validate software used in production and quality
systems.
View FDA's Warning Letters homepage (scroll
down for listing of recently posted Warning Letters).
Since we last reported on enforcement actions in March 2015, there
have been no new letters uploaded to the Office of Prescription
Drug Promotion ("OPDP") database.
View a complete listing of 2015 OPDP Warning
Letters.
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