By Jim Dickinson
A June FDA inspection at Express Diagnostics International in Blue Earth, MN, found quality system regulation violations in the firm’s manufacturing of drug of abuse test kits. A September 17 warning letter from the agency’s Minneapolis district office says that specific violations shown on an FDA-483 included the following:
- Failing to establish adequate procedures for acceptance of in-process product.
- Failing to establish adequate procedures for corrective and preventive action.
- Failing to establish adequate procedures for receiving, reviewing, and evaluating complaints.
- Failing to establish adequate procedures that define the responsibility for review and the authority for disposition of nonconforming product.
- Failing to establish adequate process control procedures that describe any process controls necessary to ensure conformance to specifications.
- Failing to validate a process whose results cannot be fully verified by subsequent inspection and test.
The district office says a follow-up inspection will be needed to determine the adequacy of the corrections the firm has reported.
Express Diagnostics 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]