FDA WARNING_LETTER - Cortechs Labs Inc - August 05, 2010

An FDA inspection of Cortechs Labs Inc. from July 30 to August 05, 2010, revealed that the firm manufactures and distributes picture archiving communications systems (PACS), which are medical devices. The inspection determined that these devices are adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act because the manufacturing methods, facilities, or controls do not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). Significant violations identified include the lack of adequately established procedures for corrective and preventive actions (21 CFR 820.100(a)), complaint handling (21 CFR 820.198(a)), and document control (21 CFR 820.40). Additionally, the firm failed to perform quality audits (21 CFR 820.22), document management review results (21 CFR 820.20(c)), complete risk analysis (21 CFR 820.30(g)), and establish procedures for purchased products and services (21 CFR 820.50). Cortechs Labs Inc. must promptly correct these violations and respond in writing within fifteen working days, outlining specific corrective steps and providing supporting documentation. Failure to comply may result in enforcement actions such as seizure, injunction, civil money penalties, and non-approval of pre-market applications for Class III devices.