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.
Bear Creek Veterinary Services Merced, CA (5/8). Inspected 11/7-12/14/06. Adulterated: Prescribed drugs to be used in an extralabel manner. For example, (purged) was prescribed for treating bacterial scours and septicemia in cattle, but it is not approved for use in cattle. The firm also prescribed penicillin G procaine for use at a dose (purged) cc whereas the approved dose is 1 cc per 100 pounds, etc. (veterinary drugs); FDCA 512(a), 501(a)(5) (3005985934)
Bridges, R. McIntyre, Jr. Shreveport, LA (5/8). Inspected 3/5-7. Violations: Investigator failed to adhere to the study protocol in that follow-up visits for all enrolled study subjects were not conducted. The investigator also failed to maintain accurate, complete, and current records of the receipt and disposition of the study devices sent by the study sponsor. The investigator was unable to account for some of the investigational devices shipped, etc. (clinical study); 21CCFR 50.20, 50.25(a), 50.27(a) (No Code)
Medico Labs Hamilton, NJ (4/16). Inspected 11/2-16/06. GMP deviations, adulterated, misbranded: Several batches were reprocessed without a scientific basis for the reprocessing method or the quantities of additional excipients or active drug substance. There was no assurance that the reprocessed batches, which represent new formulations, are assigned the appropriate expiration dating. The original failing or low assay values were not investigated and no root cause was determined. Out-of-specification assay results for several drug products had no written investigations or documentation of corrective actions, etc. (drug products such as children’s pain reliever and children’s allergy drug products); FDCA 501(a)(2)(B), 502(a)&(c), 21CFR 211.115(a), 211.192, 211.166(a), 211.160(b), 211.186(b)(4), 211.180(e)(1), 211.68(b), 211.67(a)&(b), 211.194, 201.66 (07-NWJ-10)
Sleep Devices Inc. Kissimmee, FL (3/28). Inspected 1/16. GMP deviations, adulterated: The firm has not established procedures to control the design process nor has it established and maintained written procedures to ensure that all purchased product and services conform to the specified requirements. The firm also failed to establish and maintain procedures for implementing corrective and preventive action or procedures to ensure that device history records for each batch, lot or unit are maintained, etc. (Sona sleeping pillows for snoring and sleep apnea); FDCA 501(h), 21CFR 820.30(a), 820.50, 820.100(a), 820.198(a), 803.17, 820.181(a), 820.184 (FLA-07-12)
St. Elizabeth Medical Center IRB Utica, NY (5/8). Inspected 1/16-25. Many repeat violations were observed that were cited in a 11/04 FDA letter. The IRB failed to follow written procedures for conducting initial and continuing review of research. For example, the IRB membership has listed only 12 members since 10/12/05 even though the written procedures state that the IRB shall consist of 13 members. The procedures also state that no member shall vote by proxy, but IRB minutes from 10/12/05 showed that the (purged) study was approved by proxy vote. IRB also failed to ensure that, except when expedited review procedure was used, the IRB reviewed proposed research at convened meetings at which the members present constituted a majority, etc. (device study); 21CFR 56.108(a)&(b)&(c), 56.110, 56.115(a), 56.109(f) (No Code)
University of Washington Medical Center Seattle, WA (5/8). Inspected 1/17-2/2. Deviations: Investigator failed to ensure that informed consent was obtained in accordance with regulations and failed to document informed consent. For example, the investigator failed to ensure that the information provided to a subject in order to obtain informed consent is in a language understandable by the subject. The medical record for one subject states, “interpreter needed …” There is no documentation that the consent form were translated for the subject or verification that the subject understood the forms. Protocol-required blood tests and procedures were not performed for some of the subjects enrolled, etc. (device study); 21CFR 812.100, 812.140(a)(3)(i), 50.20, 50.27(a), 812.110(b)&(c), 812.140(a) (No Code)