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

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)):**