Today FDA posted its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking on the link following each letter.

Haemacure Corp. Sarasota, FL (1/5). Inspected 11/28-29/05. QSR deviations, adulterated: The firm’s quality manual was not implemented until 11/11/05 and specifications for devices, critical components and materials were not adequately verified or tested after receipt from the supplier or the contract manufacturer. Also, procedures were not established to ensure that the quality system was established and implemented and functioned as designed. The firm failed to fully ensure that sterile products are properly validated. It also has no approved vendor agreements with contract suppliers, vendors, and manufacturers to ensure that specified requirements are met through scheduled audits, etc. (HemaMyst Piston Syringe, HemaSyst and accessories); FDCA 501(h), 21CFR 820.20(b)(3)(i) and (c), 820.22, 820.75(a), 820.50(a)(1), 820.198(a), 820.70(b), 820.80(d)&(e), 820.40(a), 820.30(a)&(j) (FLA-06-10)

International BioResources, LLC Lafayette, LA (1/20). Inspected 11/16-18, 21, 28/05. Violations: Many of the records documenting the control of critical operations are not adequately maintained or reviewed as required. For example, there was no record for 25 deferred donors in the facility’s permanent medical reject file of 33 reviewed. There was no record of the lot numbers of sterile applicators used to prepare the phlebotomy site. Firm failed to maintain written standard operating procedures including all steps in the collection and processing of blood and components for further manufacturing purposes, etc. (blood, components); FDCA 501(a)(2)(B), 21CFR 606.160(e), 606.160(a)(2), 606.100(b)&(c) (MIN 06-19)

National Genetics Institute Los Angeles, CA (1/17). Inspected two Los Angeles, CA facilities at Sepulveda Blvd. and Cotner Ave. 8/22-9/1/05. Firm did not validate computer software used as part of production or the quality system for its intended use according to an established protocol and/or failure to document the validation activities and results. It also failed to make adequate provisions for monitoring the reliability, accuracy, precision, and performance of laboratory procedures and instruments. For example, 21 of 33 databases created in (purged) are pending and have not been validated. The firm also failed to establish and maintain written standard operating procedures for steps in testing blood and components including acceptance activities such as inspections and tests, etc. (HIV-1 nucleic acid tests and HCV NAT, donor testing, and provider of test results); FDCA 501(h), 21CFR 606.140(b) &(c), 820.70(i), 820.80(a), 606.100(b), 820.100(a)(2), 820.70(a)(1) (W/L 14-06)