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

Amerilab Technologies, Inc. Plymouth, MN (3/16) Inspected 10/30 and 11/3/09. Reviewed Web site, www.drinkinmate.com. Unapproved new drug, misbranded: The Web site contains disease claims in the form of personal testimonials, including claims that trying Drinkin Mate resulted in a cure of hangover headaches. The label fails to identify the product as a dietary supplement, etc. (Drinkin Mate); FDCA 505(a), 403(q)(5)(F)(I), 403(s)(2)(B) (MIN 10-11)

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm205337.htm

Balchem Corp. New Hampton, NY(12/22) Inspected 5/20-6/10/09. GMP violations, adulterated: The firm failed to reject in-process materials required to be tested as appropriate, and approved or rejected by the quality unit. It also has not established written procedures designed to prevent objectionable microorganisms in drug products not required to be sterile. For example, 94 lots of Modified Calcium 58B and Calcium Carbonate 1551-95 (P) were released and distributed despite findings of coliform bacteria in the purified water and potable water systems, which are used in the manufacture of these products. FDA objects to the current practice “downgrading” Calcium Carbonate 58B and Calcium Carbonate 1551-95 (P) to dietary supplement ingredients when they do not meet pharmaceutical specifications. (Calcium Carbonate 58B and Calcium Carbonate 1551-95 (P)); FDCA 501(a)(2)(B), 21 CFR 211.110(c), 211.113(a), 211.160(b), 211.63 (CHI-02-10)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm204935.htm

Endogastric Solutions Inc. Redmond, WA (3/12). Inspected 9/11-30/09. Misbranded: The firm failed to submit a report to FDA after receiving information that reasonably suggested that its marketed device may have caused or contributed to a death or serious injury in that the firm was notified that the EsophyX2 had malfunctioned during a surgical operation; however, it did not report this as an MDR event. Three occurrences that were recorded by the firm as complaints failed to provide adequate documentation. For example, it failed to provide information on where in the patient’s esophagus the broken piece of device landed and what injury it caused to the esophageal tissue against which it both moved and landed, such as whether it caused or could cause significant esophageal cut, perforation or obstruction, etc. (EsophyX2 device); FDCA 502(t)(2), 501(f)(1)(B), 515(a), 502(o), 510(k), 21 CFR 803.50(a)(2), 803.17, 803.18 (SEA 10-18)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm205429.htm

Medibo N.V. Hamont-Achel, Belgium (10/2/09) Inspected 1/19-22/09. QSR deviations, adulterated, misbranded: The firm failed to adequately ensure that any complaint that represents an event which must be reported to FDA under Part 803 is promptly reviewed, evaluated, and investigated to determine whether the device failed to meet specifications. The firm also failed to maintain complaint files. It failed to conduct a complete investigation of each event to determine the cause of the event and failed to maintain copies of all MDR forms, etc. (patient lifts, and slings); FDCA 501(h), 502(t)(2), 21 CFR 820.198(d)(1), 803.50(h)(3), 803.50(a)(2), 803.18 (b)(1)(ii) (No code)

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm205451.htm

Multi-Med, Inc. West Swanzey, NH (10/7/09) Inspected 9/1-11/09. QSR deviations, adulterated: Design validation was not executed or documented in order to ensure that the devices conform to defined user needs and intended uses. A design and development plan for the NeoDevices Silicone Enteral Feeding Tube that describes or references the design and development activities and defines responsibility for implementation was not established or maintained (infant feeding tubes); FDCA 501(h), 21 CFR 820.30 (NWE-01-10W)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm205065.htm

Munroe Regional Medical Centre Ocala, FL (1/11) Inspected 9/14, 15, 21/09. The facility is not in conformance with the MDR regulations. The firm failed to maintain complete MDR event files that contain or reference all adverse event information in the possession of the reporting entity, including documentation of the deliberations and decision making processes used to determine if an device-related event was or was not reportable, etc. (EsophyX devices); FDCA 502(t)(2), 21 CFR 803.17, 803.18(b)(1)(I), 803.11, 820.198(c) &(d) (No code)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm205373.htm

Toledo, Charles H., M.D. Sylva, NC (3/11) Inspected 8/3/09 and 9/30/09. Clinical study violations: Several adverse events were not reported to the sponsor in the subjects’ electronic Case Report Form. The investigator failed to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation. He also failed to maintain adequate records of the disposition of the investigational drug, etc. (drug studies); 21 CFR 312.60, 312.62(a)&(b)&(c) (CBER-10-05)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm204871.htm

Unisource, Inc. Avon, CO (2/17) Unapproved new drugs (Dicel DM Suspension and Dicel DM Suspension ) FDCA 505(a), 502(f)(1), 505(b) or (j), (DEN-10-06 CIWL)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm204911.htm