# FDA WARNING_LETTER - Frontier Medical Products - July 09, 2010

Source: https://www.keypedia.com/records/warning_letter/frontier-medical-products/beb2e3f6-9a49-4645-a7f1-c88c38365e2a

> FDA WARNING_LETTER for Frontier Medical Products on July 09, 2010. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Frontier Medical Products
- Inspection Date: 2010-07-09
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On September 1, 2010, the FDA issued a Warning Letter to Frontier Medical Products following an inspection from June 7 to July 9, 2010. The inspection revealed that the firm's blood pressure cuffs, classified as medical devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included:
- Failure to establish procedures for design changes (21 CFR 820.30(i)), evidenced by an unverified/unvalidated change in blood pressure cuff manufacturing in April 2010, and a non-existent "Procedure for Design Change" (SOP 1244-000).
- Failure to implement corrective and preventive actions (21 CFR 820.100(a)), with the "Procedure for Risk Management" (PP1227-000) not being followed and required CAPA forms (F037) not existing.
- Failure to maintain a complaint procedure (21 CFR 820.198(a)), as a March 24, 2010, complaint was not processed per "Procedure for Complaint Processing" (PP1218-0

## Related Officers

- [Gerald J. Berg](https://www.keypedia.com/people/gerald-j-berg/ebeb00b9-51c9-4bc4-b393-bfdb01862028)

Company: https://www.keypedia.com/companies/frontier-medical-products/00c742ea-5a99-41be-b3b9-b3ee1d540f47

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861