# FDA WARNING_LETTER - SpecLinc, Inc. - June 02, 2011

Source: https://www.keypedia.com/records/warning_letter/speclinc-inc/ecc2272f-c160-4966-8c3a-e27773e48a71

> FDA WARNING_LETTER for SpecLinc, Inc. on June 02, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: SpecLinc, Inc.
- Inspection Date: 2011-06-02
- Product Type: Devices
- Office Name: New Orleans District Office
- Summary: 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

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/monica-r-maxwell/e1b3373a-80b0-4023-9aea-b4ac7170c964)

Company: https://www.keypedia.com/companies/speclinc-inc/ca8ba3f3-e6db-4f35-a862-117ae7b03cac

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea