# FDA WARNING_LETTER - Coastal Implant Technologies, Inc. - October 06, 2010

Source: https://www.globalkeysolutions.net/records/warning_letter/coastal-implant-technologies-inc/9f1081d4-3de8-4a39-aac5-4577739d0d76

> FDA WARNING_LETTER for Coastal Implant Technologies, Inc. on October 06, 2010. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Coastal Implant Technologies, Inc.
- Inspection Date: 2010-10-06
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On February 3, 2011, the FDA issued a Warning Letter to Coastal Implant Technologies, Inc. following an inspection from August 31, 2010, to October 6, 2010. The inspection revealed that the firm, identified as a manufacturer (specification developer) of Coastal Implant Technologies brand, Newport (Straight-wall) and Sunset (Cylindrical-wall) endosseous dental implants, was in violation of Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included:
1.  **Failure to establish and maintain procedures for purchased products and services (21 CFR 820.50):** The firm lacked procedures and records to ensure conformity of contract-manufactured dental implants. Their claim of being only a distributor was deemed inadequate due to the absence of a written agreement with their manufacturer and lack of visual inspection records.
2.  **Failure to establish and maintain design control procedures (21 CFR 820.30(a)):** No procedures, records, or files existed for the design and development of their dental implants. The firm's assertion that the manufacturer handled design controls was insufficient without a written purchasing control agreement.
3.  **Failure to establish and maintain procedures for nonconforming product control (21 CFR 820.90(a)):**

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)
- [Steven S. Grand](https://www.globalkeysolutions.net/people/steven-s-grand/c815f6f0-cd19-41bd-91f7-ac038c9015ad)

Company: https://www.globalkeysolutions.net/companies/coastal-implant-technologies-inc/62b04065-ed8a-4ccf-aa2d-b47d27321466

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