Gresco Products, Inc. – FDA Warning Letter, Jun 20, 2011

On May 24, 2011, an FDA inspection of Gresco Products, Inc. in Stafford, Texas, revealed that the firm, which manufactures dental prosthetics, was not in conformity with current good manufacturing practice (CGMP) requirements of the Quality System regulation (21 CFR Part 820). The firm's response dated July 12, 2011, was deemed inadequate due to a lack of documentation for implemented corrections and corrective actions.

Violations included: 1. Failure to establish and maintain procedures for corrective and preventive action (21 CFR 820.100(a)). 2. Failure to establish and maintain adequate procedures for finished acceptance, with instances of unrecorded QC tests, missing release criteria, and unperformed tests (21 CFR 820.80(d)). 3. Failure to adequately establish and maintain procedures for acceptance of incoming products, including unlogged raw materials, undefined evaluation methods, and lack of written procedures for metal alloy verification (21 CFR 820.80(b)). 4. Failure to establish and maintain adequate procedures for design changes, with undocumented changes to labeling and syringe sizes (21 CFR 820.30(i)). 5. Failure to establish and maintain adequate procedures for ensuring purchased products and services conform to requirements, including inadequate supplier evaluation procedures and undocumented changes in raw material concentration