FDA posted its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking on the link following each letter.
G&B Electronic Designs, Ltd. Bordon, Hampshire, UK (4/24). Inspected 11/20-23/06. QSR deviations, adulterated, misbranded: Automated machines were used for screening, placing, and soldering processes for the circuit boards used in the NicoletOne device, but no procedures were established to validate the processes to assure that specified requirements were met. Company failed to assure that when computers or automated data processing systems are used as part of production or the quality system, the manufacturer validates the computer software for its intended use. For example, electronic records were used, but there was no software validation, etc. (Traclt and NicoletOne ambulatory electroencephalograph recorder devices); FDCA 501(h), 502(t)(2), 502(o), 510, 21CFR 830.75(a), 820.70(i), 90(a), 806.10, 807, 807.40(a) (No Code)
http://www.fda.gov/foi/warning_letters/s6338c.htm
LifeCare Technologies, Inc. Tampa, FL (4/2). Inspected 8/21-23/06. QSR deviations, adulterated, misbranded: The firm failed to document structural testing of its P.I.N. software, including independent code reviews. It also lacks documentation of validation of its compiler. The firm does not have documentation of the reasoning for all significant changes to the P.I.N. software since 1990. Of 30 call tickets received 5/06, 14 appeared to be complaints, but they were not identified as such, etc. (Perinatal Information Network software); FDCA 501(h), 501(f)(1)(B), 502(t)(2), 502(o), 21CFR 820.30(g), 820.30(i), 820.100(a)(4), 820.198(a), 820.25(b), 803.50(b), 803.18 (FLA-07-14)
http://www.fda.gov/foi/warning_letters/s6333c.pdf
TMED, Inc. Columbia, TN (4/18). Inspected 1/1-11. QSR deviations, adulterated: Company failed to adequately establish and maintain procedures for implementing corrective and preventive action. For example, CAPA procedures do not include procedures for investigating the cause of nonconformities relating to product, processes, and the quality system. Company also failed to adequately include, or refer to the location of, in the device master record the device specification, including appropriate drawings and packaging and labeling specifications. The general manager stated that he was unaware of any quality audits conducted since 1/03, etc. (blood pressure cuffs); FDCA 501(h), 502(t)(2), 21CFR 820.100(a), 820.181, 820.184, 820.22, 803.17 (2007-NOL 10)
http://www.fda.gov/foi/warning_letters/s6335c.pdf
ViroMed Laboratories Minnetonka, MN (3/30). Inspected 10/26/06-1/12/07. Violations: Company failed to follow the test kit manufacturer's instructions and its written procedures for performing relevant communicable disease testing of donor specimens. Between 11/22/05, and 2/24/06, donor specimens from 47 living reproductive tissue donors that tested initially reactive by the (purged) HIV-1/HIV-2 PLUS 0 Enzyme Immunoassay were not retested in accordance with the manufacturer's test kit instructions and the firm's standard operating procedure. Company failed to verify corrective actions relating to core CGTP requirements to ensure that such actions are effective and are in compliance with CGTP, etc. (human cells, tissues, and cellular and tissue-based products); 21CFR 1271.80(c), 21 CFR 1271.47(a), 1271.160(b)(3) (MIN-07-16)
http://www.fda.gov/foi/warning_letters/s6331c.pdf
