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Latest FDA Warning Letters


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

Apotex, Inc. Toronto, ON, Canada (2/21). Inspected Ontario, Canada facility 8/13-24/12 and inspected the Toronto, Canada facility 10/18-26. Violations: The firm failed to perform adequate unidirectional airflow pattern studies (i.e., smoke studies) for the aseptic filling line used for the production of (purged) Injection. It also failed to establish maximum holding times for vials used in media fills, prior to incubation, etc. (finished pharmaceuticals); FDCA 501(a)(2)(B), 21 CFR 211.113(b), 211.192

Body, Mind & Soul, Inc. Toronto, Ontario, Canada (3/13). Adulterated: The firm is marketing the Celluderm, a therapeutic massager, for other intended uses. For example, the firm’s Web site states, “Celluderm treatment progressively wears down congestion by manipulating body tissue using a vacuum suction massage,” etc. (Celluderm); FDCA 501(f)(1)(B), 502(o), 510(k), 520(g), 510(j)

Fisioline, s.r.l. Verduno, Italy (3/5). Inspected 10/29-11/1/12. QSR deviations, adulterated: The firm’s complaint handling procedures do not include a requirement that ensures all complaints are evaluated to determine whether it should be filed as a Medical Device Report. The software developed by the firm to record, evaluate, investigate, correct and repair incoming technical assistance calls, complaints, and service records was implemented in 10/2012, and has not been validated. Also, no validation documentation was available for an established protocol, any testing data, or a finished report for the validation of this system, etc. (Lumix 2 and Lumix 3 laser devices); FDCA 501(h), 502(t)(2), 21 CFR 820.198(a)&(b)&(e), 820.70(i), 820.30(f)&(g), 820.100(a), 820.90(b)(1). 820.72(a)&(b)(2), 820.80(e), 820.22, 803.17 http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm344747.htm

Fresenius Medical Care, North America Waltham, MA (3/5). Inspected Ogden, UT facility 11/26-12/7/12. QSR violations, adulterated: The firm failed to establish and maintain adequate procedures for verifying the device design. The company response was inadequate in that the updated biocompatibility testing did not address whether or not platelet adsorption was assessed, and the design validation report, dated 12/27/00 did not evaluate the effect of (purged) dialyzers on platelet adhesion, etc. (Optiflux Polysulfone Dialyzers); FDCA 501(h), 21 CFR 820.30(f)&(g),

Hyphen BioMed Neuville Sur Oise, France (9/5/12). Inspected 6/18-20/12. GMP violations: The firm failed to establish and maintain adequate procedures for implementing corrective and preventive action. Its process for controlling nonconforming products (Processing Defects, Corrective and Preventive Actions- P830-01) includes the disposition of “accept as such.” Defect # 198 does not include a process for documenting the justification for use of nonconforming product, etc. (biological reagents for hemostasis and thrombosis including heparin assay); FDCA 501(h), 21 CFR 820.100(a)(1), 820.90(b)(1)&(2), 820.72(a), 820.40, 820.22, 820.184

Instratek, Inc. Houston, TX (8/23/12). Inspected 4/2-24/12. QSR deviations, adulterated: The firm failed to establish and maintain adequate procedures for validating the device design to ensure that the devices conform to defined user needs and intended uses. For example, it has not validated the pre-vacuum steam sterilization cycles in the instructions for use of product labeling for the SubTalar Lok System and Michelangelo Bunion System (MABS) supplied to customers, etc. (orthopedic implant systems and associated instruments for surgery of the hand and foot); FDCA 501(h), 21 CFR 820.30(g), 820.30(c), 820.80(d), 820.100, 820.198(a)

Keystone Labs Bozeman, MO (3/18). Inspected 8/15,16, 20, 21, 23, and 29/12. GMP violations, adulterated, misbranded: The firm failed to fulfill its registration obligations under FDCA 510(i)(1). It also failed to maintain buildings used in the manufacture, processing, packing or holding of drug products in a good state of repair. For example, the investigator observed condensate leaking into a bucket that was secured to the ceiling over the production area, and peeling paint on the floors, walls and support beams in the production area. It failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance, etc. (finished pharmaceuticals); FDCA 505(a), 502(f)(2), 502(c), 502(e)(1)(A)(ii), 510(i)(1)&(2), 510(j), 502(c), 21 CFR 211.58, 211.63, 211.67(a), 211.84(a), 211.84(d)(6), 211.100(b)

USA Far Ocean Group/Health & Beauty Group Inc. Alhambra, CA (10/24/12). Misbranded: FDA confirmed through laboratory analyses that the products, “U-Prosta,” “Male Enhancer,” and “X-Hero,” contain terazosin, tadalafil, and sulfosildenafil, respectively, but none of these ingredients were found on the product label, etc. (dietary supplements); FDCA 403(r)(6), 502(f)(1), 502(a)