Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Gambro Dialysatoren, GmbH Hechingen, Germany (9/4). Inspected 5/4-7. The firm failed to submit an MDR report for an event within the 30-day timeframe. For example, the firm received a complaint involving a device identified as the Polyflux 24 R. The device experienced a blood leak and corrective action was taken to prevent the leaking. Because the device is considered to be a life-sustaining device, this malfunction would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, etc. (dialyzers for hemodialysis); FDCA 502(t)(2), 21 CFR 803.50(a)(1)&(2) (No code)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm185874.htm

Pantheon Research Venice, CA (9/3). Unapproved device, adulterated, misbranded: Reviewed Web site at www.pantheonresearch.com. The materials posted on the site indicate that the products are “lectroacupuncture stimulators” to be used during auricular electroacupuncture, facial electroacupuncture, and body electroacupuncture, for transcutaneous electrical nerve stimulation (TENS) (Electro-Stimulator products — models 4c.Pro, 6c.Pro, 8c.Pro, 12c.Pro PENS, 6c3i.Pro PENS); FDCA 501(1)(I)(B), 502(o), 520(g) (No code)

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm186104.htm

Phoenix Bio-Tech Corp. Mississauga, Ontario, Canada Inspected 5/11-14. GMP deviations, adulterated: The firm failed to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. It failed to provide, when requested, a design control documentation for the design of the TREP-CHEK Treponemal Antibody EIA. The firm also did not establish and maintain procedures for identifying, documenting, validating , or where appropriate verifying, review and approval of design changes before their implementation, etc. (TREP-SURE Anti-Treponema EIA Screen and the TREP-CHEK Anti-Treponema EIA.); FDCA 501(h), 502(t)(2), 21 CFR 820.30(a)(1)&(i) (No code)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm185865.htm

Sumitomo Chemical Co. Ltd. Gifu Prefecture, Japan (8/24). Inspected 4-6-9. CGMP violations, adulterated: The firm does not assure that suitable processing is used for the (purged) step of the hydralazine HCI manufacturing process. It currently uses (purged) and does not test this for endotoxins and total microbial count. The firm’s (purged) system is not designed to minimize the risk of microbial contamination. The new method validation for bicalutamide API did not include sensitivity (limit of quantitation), linearity, accuracy, or an appropriate precision determination, etc. (active pharmaceutical ingredients); FDCA 501(a)(2)(B) (WL: 320- 09-11)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm185648.htm