This week FDA posted its latest batch of Warning Letters. It can be downloaded in PDF format by clicking on the link following each letter.
Bradford, Michael Nevada Orthopedic & Spine Center Las Vegas, NV (10/1). Inspected 2/16-3/20. The investigator failed to obtain informed consent in accordance with regulations for protecting human subjects. Three subjects were enrolled who failed to meet study eligibility criteria. The investigator also failed to maintain accurate, complete, and current records of each subject’s case history and exposure to the device. All worksheets used to screen the subjects (original source documents) were discarded after the information was transcribed to a case report form, etc. (device study); FDCA 520(g), 21CFR 812.100, 50.20, 812.110(b), 812.140(a)(3) (No Code)
http://www.fda.gov/foi/warning_letters/s6526c.pdf
Chiu Technical Corp. Kings Park, NY (9/24). Inspected 4/19-5/1. QSR deviations, adulterated, misbranded: The firm has not established and maintained quality system procedures for complaint handling, corrective and preventive action, non-conforming products, purchasing controls, acceptance activities, and device labeling. It has not established and maintained procedures for management review to ensure that the quality system is maintained. The firm also failed to furnish material or information required under the Medical Device Reporting regulation, etc. (Transilluminator, Model BFO-150); FDCA 501(h), 502(t)(2), 501(f)(1)(b), 515(a), 502(o), 21CFR 820.20(c)&(e), 820.198(a), 820.100(a), 820.90, 820.50, 820.80(a), 820.120, 820.22, 820.181(a), 820.184, 803.17, 803.50(a)(1), 803.50(3) (NYK 2007-20)
http://www.fda.gov/foi/warning_letters/s6527c.pdf
Med-South Pharmacy, Inc., dba Partners in Care Orange Beach, AL (9/28). Inspected 12/20-21/06. The investigation was initiated in response to reports of injuries related to a product made by the company. Unapproved new drugs: The firm produces large volumes of injectable products which are copies or essentially copies of FDA-approved, commercially available products. The production of the volume the company produced between 1/1/06 and 12/31/06 of FDA-approved, commercially available products is inconsistent with traditional pharmacy compounding. The company purports to be a compounding pharmacy, but the firm’s operation exceeds the scope of traditional pharmacy practice. The drugs are misbranded because the labeling fails to bear adequate directions for use. The company’s manufacturing process has not been validated for its injectable drug products. The company conducts testing on the concentration of the active ingredient for injectable drug products on a monthly basis only, etc. (betamethasone acetate/betamethasone sodium phosphate multi-dose injectable drug product); FDCA 505(a), 502(f)91), 502(o), 501(a)(2)(B), 301(a), 21CFR 211.113(b), 211.167(a), 211..80(b), 211.165(a)&(f), 211.80(b), 211.100(a)&(b), 211.160(b), 211.22(a), 211.84(d)(2), 211.192, 211.137(a), 211.166(a), 211.130(b), 211.188(b), 211.67(b), 211.80(a), 211.68(a), 21.160(b)(4), 211.125(f), 211.170(b), 211.182, 211.25(a), 21184(e), 211.103 (2007-NOL-16)
http://www.fda.gov/foi/warning_letters/s6529c.pdf
Medtronic, Inc. Memphis, TN (10/1). Reviewed surgical technique manual for the Satellite Spinal System provided by the company 7/20. Adulterated, misbranded: Company does not have an approved PMA or an IDE for the device. The company did not notify the agency of its intent to introduce the device into commercial distribution as required by Sec. 510(k) of the FD&C Act. The manual includes intended uses and indications that represent major changes or modifications in the device’s intended use and design requiring either a new 510(k) or PMA. The manual does not include a step for the implantation of bone graft, contrary to the cleared intended use of the device. The manual also describes a non-fusion procedure, in that there is no specific mention of either bone graft insertion or bony fusion, contrary to the statement which FDA requires to be displayed: “The safety and effectiveness of this device for use in motion sparing, non-fusion procedures has not been established,” etc. (Satellite Spinal System); FDCA 501(f)(1)(b), 515(a), 520(g), 502(o) (No Code)
http://www.fda.gov/foi/warning_letters/s6525c.pdf
