# FDA WARNING_LETTER - MB Industria Cirurgica Ltda - March 16, 2017

Source: https://www.keypedia.com/records/warning_letter/mb-industria-cirurgica-ltda/10bd9073-3e4c-4bc1-b9c9-52822f53d029

> FDA WARNING_LETTER for MB Industria Cirurgica Ltda on March 16, 2017. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: MB Industria Cirurgica Ltda
- Inspection Date: 2017-03-16
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On March 13-16, 2017, an FDA inspection of MB Industria Cirurgica Ltda in Paulista, Brazil, revealed that their wound dressings are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include:
1.  **Process Validation (21 CFR 820.75(a))**: Failure to validate manufacturing processes for the (b)(4) device, including (b)(4) and packaging to ensure sterility.
2.  **Environmental Control (21 CFR 820.70(c))**: Lack of documentation for cleanroom installation/testing (ISO 14644), non-compliance with cleanroom specifications (ISO Class 8 instead of Class 7, temperature excursions), inadequate procedures for cleanroom conditions after power outages, and no environmental control program for cleanliness/biocontamination.
3.  **CAPA (21 CFR 820.100(a))**: Inadequate procedures for corrective and preventive actions, failing to analyze quality data (e.g., increased leakage complaints) and disseminate quality problem information.
4.  **Complaint Handling (21 CFR 820.198(a))**: Inadequate procedures for timely processing, documenting oral

## Related Officers

- [Mr.](https://www.keypedia.com/people/alan-dishman/454cbc80-0449-42d0-8214-5ea912112ced)
- [Office Director](https://www.keypedia.com/people/sean-m-boyd/e9ac4789-b489-402d-8fb7-e20eed2af01f)

Company: https://www.keypedia.com/companies/mb-industria-cirurgica-ltda/edc58295-1325-46b9-837f-053a09b1b18f

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7