Polymer Technologies Systems, Inc. – FDA Warning Letter, Mar 5, 2008

The FDA conducted an inspection of Polymer Technology Systems, Inc. (Indianapolis, IN) from February 4 to March 5, 2008, identifying significant violations of Current Good Manufacturing Practice (CGMP) for medical devices, specifically the Quality System (QS) regulation (21 CFR Part 820). The firm manufactures CardioChek meters, classified as medical devices.

The inspection revealed the devices are adulterated under section 501(h) of the Act due to non-conformance with CGMP requirements. Key violations include: 1. **Design Control (21 CFR 820.30(a), 820.30(j)):** Failure to implement design control procedures for CardioChek/CardioChek PA meters (versions 2.22 to 2.30) throughout all design stages, with design changes approved two years after production began. Design history files lacked evidence of development per a design plan. 2. **Complaint Handling (21 CFR 820.198(a), 820.198(b)):** Misclassification of five calls as inquiries instead of complaints, leading to inadequate review. Failure to evaluate returned meters for a complaint involving out-of-tolerance recovery. 3. **CAPA Procedures (21 CFR 820.100(a)(1), 820