Today FDA posted its latest batch of Warning Letters. They can be downloaded in Adobe PDF format by clicking on the link following each letter.
Eastview Veterinary Clinic Penn Yann, NY (10/27). Inspected 6/2,4,10/03. Deviations, adulterated, misbranded: A patient medical record for Mr. (purged) showed that veterinarians from this practice visited Mr. (purged) dairy farm a number of times and prescribed and dispensed on four occasions. Mr. (purged) was directed to use the drug for the treatment of all classes of adult dairy cattle at his discretion, without having a veterinarian diagnose and evaluate the conditions for which the drug was to be used. Clinic’s prescription label fails to conform to 21CFR 530.12 in that the labeling fails to include the class/species or identification of animals being treated, the dosage frequency and duration of treatment, and any appropriate cautionary statements, etc. (veterinary drugs); FDCA 501(a)(5), 502(t)(1), 502(f)(1), 21CFR 530.20(a)(2), 530.12 (NYK 2004-01)
Medi-Stat Inc. Littleton, CO (10/17). Inspected 5/9-21/03. GMP deviations, adulterated: There was no documentation to demonstrate that the sterilization, application of plastic laminate, or the use of cleaning agents on the pulse oximeter sensors did not adversely affect the safety or operation of the devices. There was no documentation to show the final testing used by Medi-Stat assures that the devices meet the original equipment manufacturers’ specifications. Device history records were incomplete and one DHR did not contain information on all the required processing steps, acceptance records or the approval signature. Medi-Stat’s audit procedure did not address the areas to be audited, the audit frequency or the performance of re-audits if necessary, etc. (reprocessed single-use pulse oximeter sensor devices); FDCA 501(h), 21CFR 820.75(a), 820.30, 820.184, 820.22, 820.72 (DEN-04-01)