# FDA WARNING_LETTER - Applied Medical Technology Inc - April 29, 2011

Source: https://www.globalkeysolutions.net/records/warning_letter/applied-medical-technology-inc/76fb4b82-f547-43c8-b9b9-d33511d99c26

> FDA WARNING_LETTER for Applied Medical Technology Inc on April 29, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Applied Medical Technology Inc
- Inspection Date: 2011-04-29
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On June 8, 2011, the FDA issued a Warning Letter to Applied Medical Technology, Inc. following an inspection from April 11-29, 2011, which found their sterile gastroenterology feeding tubes to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation (21 C.F.R. Part 820).

Key violations include:
1.  **Complaint Handling (21 C.F.R. § 820.198(c)):** Failure to establish adequate procedures for thorough complaint investigations, exemplified by an insufficient investigation into a "balloon burst" complaint.
2.  **Corrective and Preventive Action (CAPA) (21 C.F.R. § 820.100(a)(1)):** Failure to adequately analyze quality records and work operations to identify causes of nonconforming product, specifically not capturing or analyzing machining scrap and not monitoring scrap rates.
3.  **Nonconformity Investigation (21 C.F.R. § 820.100(a)(2) and (3)):** Failure to investigate the cause of high injection molding scrap rates (e.g., 46% for lot #100909

## Related Officers

- [Teresa C. Thompson](https://www.globalkeysolutions.net/people/teresa-c-thompson/b41b98e5-2a7c-4f19-923b-058a197a8fd4)

Company: https://www.globalkeysolutions.net/companies/applied-medical-technology-inc/be98a0a7-706f-43d8-bb77-f99acd317236

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