SpecLinc, Inc. – FDA Warning Letter, Jun 2, 2011

During a May 31-June 2, 2011, inspection, the FDA found SpecLinc, Inc., a manufacturer of OTREC® otoscope specula, in violation of Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). The firm's products are considered adulterated under Section 501(h) of the Act.

Key violations include: 1. **Complaint Handling (21 CFR 820.198(a)):** Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints, including determining if Medical Device Reporting (MDR) is required. No complaint procedure or files exist. An example cited a May 24, 2011, complaint about "damaged otoscope speculums" with "damaged tips" that "cannot be safely used," which was only documented by a note about "flash on tip of specula" and reimbursement. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** Failure to establish CAPA procedures, including analyzing data sources, investigating nonconformities, identifying corrective actions, verifying effectiveness, implementing changes, disseminating information, and submitting for management review. 3. **Production Process Controls (21 CFR 820.70(a)):** Failure