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.
Chosen Valley Veterinary Clinic Chatfield, MN (9/21). Inspected 5/31 and 6/6. The new animal drugs sulfadimethoxine and gentamicin sulfate are adulterated because they were used in a manner that did not conform with their approved uses or the regulations for Extralabel Drug Use in Animals. The veterinary practice was also compounding and distributing an unapproved new animal drug, GM 100. The practice is not taking appropriate measures to guard against illegal drug residues. It prescribed and dispensed sulfadimethoxine 12.5% oral solution for intravenous use to treat mastitis in lactating dairy cattle, an extralabel use which is prohibited. The practice also prescribed and dispensed products containing gentamicin sulfate for extralabel use (scours and pneumonia in calves) without establishing a substantially extended withdrawal period, supported by appropriate scientific information, etc. (sulfadimethoxine 12.5% oral solution, gentamicin sulfate); FDCA 512(a), 501(a)(5), 21CFR 530 (MIN 05-22)
Houchin Blood Services Bakersfield, CA (9/21). Inspected 6/13-17/05. GMP deviations, adulterated: The facility failed to follow the manufacturer’s instructions when performing confirmatory tests on blood and blood components. Consignees are not notified within 72 hours of a repeat reactive HIV result for purposes of quarantine. The facility lacks written procedures to look at prior donations of whole blood, blood components, source plasma, and source leukocytes, when a donor of blood subsequently tests repeatedly reactive for antibody to HIV, or otherwise is determined to be unsuitable when tested, etc. (blood and components); FDCA 501(a)(2)(B), 21 CFR 606.65(e), 610.46(a)(1), 606.100(b)(19), 606.100(b)(1), 630.6(c) (2974534)
Tyco Healthcare Group Mansfield, MA (9/27). Inspected 1/18-3/24. GMP deviations, adulterated: The design validations for tracheostomy tubes do not use initial production units from the facilities where they are or where they will be manufactured. Also there was no scientific evidence proving that the devices used for the design validation were equivalent to initial production units. The company failed to establish and maintain design input procedures that include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. Tyco did not review and evaluate all complaints to determine whether an investigation was necessary, and did not maintain a record that includes why no investigation was made if applicable, etc. (endotracheal/tracheostomy tubes and accessories, temperature monitoring and disposables, infusers, irrigators, respiratory support products, patient warming and blood/fluid warming disposables, oximetry sensors, manual resuscitators, and other respiratory supplies, pulse oximetry monitors, ventilators and accessories, sleep apnea therapy products, etc.); FDCA 501(h), 502(t)(2), 21CFR 820.30(c)(g), 820.198(a), 820.198(b), 820.100(a)(1)(3), 820.100(b), 820.50, 820.160(b)(4), 820.250(a), 820.20, 820.22, 803 (No Code)