By Jim Dickinson
An FDA inspection at Amgen in Thousand Oaks, CA, last June found Quality System Regulation violations in the firm’s manufacturing of several drug-device combination products.
The products affected were the osteoporosis medicine Prolia with prefilled syringe and manual needle guard, the arthritis and psoriasis drug Enbrel lyophilized vial and diluent with vial adapter, and the Enbrel prefilled syringe with Sureclick 1.5 auto injector.
According to a recent warning letter from the agency’s Los Angeles District Office, the three items are combination products with device constituent parts, and it is the device parts that had Quality System violations. Specific violations listed on a FDA-483 included:
- Failing to establish (define, document, and implement) and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses, including testing of production units under actual or simulated use conditions.
- Failing to establish and maintain procedures for identifying, documenting, validating or, where appropriate, verifying, reviewing, and approving design changes before their implementation.
- Failing to establish and maintain requirements that must be met by suppliers, contractors, and consultants.
The firm’s responses were inadequate, the letter says. Amgen was told to take prompt action to correct the violations and to respond with a list of specific steps taken, documentation of each step, and a timetable for completion.
Jim Dickinson is MD+DI's contributing editor.
[image courtesy of KIBSRI/FREEDIGITALPHOTOS.NET]