Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Crothall Healthcare, Inc. Wayne, PA (12/29). Inspected Steripac, located at 606 32nd Street South, Birmingham, AL 7/27-30/09. QSR deviations, adulterated: The firm has not established or implemented written procedures for implementing CAPA. The only management official on site explained he was not aware of the requirements. The firm’s complaint handling procedures do not include a requirement that all complaints be evaluated for MDR reportability. The device master records for the Gown Pack (G-2) and the Towel Pack (T-12) do not include or refer to the location of the production and process specifications including the appropriate equipment specifications, production methods, and production procedures for manufacturing the devices, etc. (sterile surgical linen packs); FDCA 501(h), 502(o), 820.100(a), 820.90(a), 820.198(a)(3), 820.80(e), 820.50, 820.181(b), 820.40, 820.20(c) (2010-NOL-06)
Micro Current Technology, Inc. Seattle, WA (12/24). Inspected 7/20-22/09. Unapproved device, adulterated, misbranded (Platinum Nano Microcurrent System (bt-nano), and the Bio-Therapeutic, Inc., Bio-Ultimate Platinum Microcurrent System); FDCA 501 (f)(1)(B), 515(a), 502(o) (SEA 10-09)
Penumbra, Inc. Alameda, CA (12/31). Inspected 7/29-8/28/09. QSR deviations, adulterated: The firm initiated an exchange action on 4/23, which after the FDA inspection took place, was classified as a Class I recall, yet the firm’s corrective action did not require all customers to be notified. The corrective action of pulling old product off the market and exchanging for new product only occurred upon a direct physician request or sales representative initiation. At the time of the inspection, the firm did not know what nonconforming Neuron 070 product remained in the market unused. During initial distribution of the products, to include Penumbra Neuron 053, 070 and Advanced 070, physician evaluations submitted to the firm were not reviewed as potential complaints or medical device report, etc. (Neuron Intracranial Access System, Models 053, 070, Advanced 070); FDCA 501(h), 502(t)(2), 21 CFR. 820.100(a), 820. 198(a) and (d), 820.90(a), 820.75(a), 820.140, 806.10(b) (No code)
Victus, Inc. Miami, FL (12/21). Inspected 4/20-22. QSR deviations, adulterated, misbranded: The firm received a complaint about “clogging” of the Secure Flow infusion pump and a complaint of “leakage” at the Y-connector on the Dosi-Flow LV. Administration set. According to the firm’s Complaint Report Form, 05-FOR-006, for both complaints, there is no indication that either of these complaints was evaluated to determine if the events were reportable under the Medical Device Reporting regulation. The firm also failed to conduct quality audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. There have been multiple changes to the IV Administration Sets that are not cleared by FDA, etc. (sterile, IV (intravascular) infusion devices); FDCA 501(f)(1)(B), 501(h), 502(o), 21 CFR 820.198(a)(3), 806.10(a) & (b) (FLA-10-06)