FDA WARNING_LETTER - Medefil Incorporated - February 11, 2010

The FDA issued a Warning Letter to Medefil, Incorporated following an inspection from December 1, 2009, to February 11, 2010, which found that their Heparin and Normal Saline I.V. Flush Syringes were adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act. The manufacturing, packing, storage, or installation methods and controls were not in conformity with the 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 adequate procedures for corrective and preventive action (21 CFR 820.100(a))**: Procedures lacked document control for cancelled investigations, leading to deletion of CAPAs without explanation. 2. **Failure to identify actions needed to correct and prevent recurrence of nonconforming product (21 CFR 820.100(a)(3))**: Temperature excursions in a refrigerator were not investigated, and a recommended replacement was not implemented. 3. **Failure to verify and validate corrective and preventive actions (21 CFR 820.100(a)(4))**: Procedures did not adequately ensure effectiveness and non-adverse impact on finished devices, as seen in multiple nonconformance reports. 4. **Failure to establish and