Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
GVS Filter Technology UK Ltd. Lancashire UK (1/23). Inspected 7/21-24/14. QSR deviations, adulterated: The firm’s CAPA procedures do not include requirements for: analyzing applicable sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems; and verifying or validating corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device. The firm also failed to validate processes with a high degree of assurance, where the results of a process cannot be fully verified by subsequent inspection and test, etc. (Class II air filters and spirometers); FDCA 501(h), 21 CFR 820.100(a)&(b), 820.198, 820.75(a), 820.90(b)(1)&(2), 820.30(g), 820.50(b), 820.80(e), 820.250(b), 820.22
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm441927.htm
Stanmore Implants Worldwide Ltd. Elstree, UK (11/26/14). Inspected 7/28-31/14. QSR deviations, adulterated: The firm’s Corrective and Preventive Action (CAPA) is deficient in that it does not require the use of appropriate statistical methodology, where necessary, to detect recurring quality problems and does not include requirements for the documentation of all CAPA activities. The complaint handling procedure is also deficient in that it does not include requirements to ensure that complaints are processed in a uniform and timely manner, oral complaints are documented upon receipt, and that complaints are evaluated for MDR reportability, etc. (implantable extendable femoral and total knee replacement devices); FDCA 501(h), 502(t)(2), 21 CFR 820.100, 820.198, 820.30(j), 820.184, 820.22, 803.17
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm441885.htm
Visionary Contact Lens dba Visionary Anaheim, CA (4/3). Inspected 1/27-2/26. QSR deviations, adulterated: The firm failed to adequately validate software used as part of production and quality systems for its intended use according to an established protocol. It also failed to establish and maintain procedures for implementing corrective and preventive action, including investigating the cause of nonconformities relating to product, processes, and quality system, etc. (rigid gas permeable contact lenses); FDCA 501(h), 21 CFR 820.70(i), 820.70(g), 820.100(a)(4), 820.100(a)(2), 820.22, 820.25(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm441879.htm
