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.
Applied Water Engineering, Inc. Salt Lake City, UT (12/27/06). QSR deviations, adulterated, misbranded: Design changes were not documented or reviewed for the transformation of the older model into the newer model. The firm lacked complete drug history files for each type of device. The firm’s procedures did not address the analysis of service repairs or defective component complaints. Customer service calls were not being adequately documented as required. The firm only maintained invoice records of parts sold to a customer and replacement parts sold to remedy a problem with a device. Because it did not adequately document service calls, it was unable to determine if the calls were an MDR reportable event, etc. (PA2000 and SPD reverse osmosis water purification systems for dialysis and the Bicarb Mixer); FDCA 501 (h), 501(f)(1)(b), 515(a), 502(o), 510(k), 21CFR 820.30(i)(j), 820.200, 820.70(a)(1), 820.80(d), 820.25(b), 820.184, 820.20(b)&(c), 820.22, 803.17 (DEN-07-03)
http://www.fda.gov/foi/warning_letters/g6199d.pdf
Biotecx Laboratories, Inc. Houston, TX (12/8/06). Inspected 9/5-8, 11, 22, and 25/06. QSR deviations, adulterated: The firm failed to establish and maintain adequate procedures for finished device acceptance. For example, it did not calculate the zero binding for the T4 Standard Lot #2618 released on 10/7/03. During the inspection the firm calculated the zero binding values and found them to be outside its approved binding specification. Yet the lot of T4 standards was used in all of the T4 EIA kits manufactured in the last two years. The firm also changed the user test procedure in the product insert of the T4 EIA Kit and the expected testing ranges of euthyroid without conducting appropriate testing and documenting an explanation to determine the impact of the changes on patient test results. At the time of the inspection, the firm was not able to provide stability test results that confirm and document the expiration dates for the reagents in the T4 EIA kit, etc. (Opticoat T3 and T4 EIA enzyme immunoassay) kits); FDCA 501(h), 21CFR 820.80(d)&(e), 820.70(b), 820.30(g), 820.72(a)&(b)(1) (2007-DAL-WL-2)
http://www.fda.gov/foi/warning_letters/g6197d.pdf
