FDA WARNING_LETTER - Cook Inc. - July 16, 2014

The FDA issued a Warning Letter to Cook, Inc. following an inspection from June 17 to July 16, 2014, at their Bloomington, Indiana facility, which manufactures vascular implants and intravascular catheters. The inspection revealed that the firm's devices are adulterated under section 501(h) of the Act, as their manufacturing methods, facilities, or controls do not conform to the Quality System regulation (21 CFR Part 820). The firm's responses dated August 7 and September 12, 2014, were deemed inadequate due to a lack of documentation for corrective actions. Key violations include failures in process validation (21 CFR 820.75(a)), process monitoring (21 CFR 820.75(b)), and establishing/maintaining Corrective and Preventive Action (CAPA) procedures (21 CFR 820.100), specifically regarding data analysis, nonconformity investigation, and corrective action verification. Further deficiencies were noted in procedures for incoming product acceptance (21 CFR 820.80(b)), control of nonconforming product (21 CFR 820.90(a)), statistically valid sampling plans (21 CFR 820.250(b)), and ensuring purchased products conform to requirements (21 CFR 820.50). The FDA requires prompt corrective action and a written plan within fifteen business days, noting that completion dates beyond April 2015 are unacceptable. Failure to comply may lead to regulatory actions, including seizure, injunction, civil money penalties, and impact on federal contracts, premarket approvals, and Certificates to Foreign Governments.