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

Americare Compounding, LLC. Garden City South, NY (4/22). Inspected 6/3-19/13. Adulterated, misbranded: The investigators noted that the firm was not receiving valid prescriptions for individually identified patients for a portion of the drug products that it was producing. Also the investigators observed serious deficiencies in the firm’s practices for producing sterile drug products. The firm’s operators performed aseptic operations wearing gowns that can be reused for a week and the firm did not use a disinfectant with sporicidal properties in the cleanroom. Also, the firm failed to demonstrate through appropriate studies that its hoods are able to provide adequate protection of the ISO 5 area in which sterile products are processed. It also failed to adequately design the facility with adequate separation or defined areas or such other control systems necessary to prevent contamination or mix-ups, etc. (sterile drug products); FDCA 502(f)(1), 501(a)(2)(B), 21 CFR 211.113(b), 211.28(a), 211.42 (b)&(c)(10)(iv)&(v), 211.165(a), 211.166(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm394485.htm

Instituto Bioclon S.A. de C.V. Mexico City, Mexico (4/16). Inspected 1/14-23/14. GMP deviations, adulterated: The firm failed to assure that appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, are established and followed. The firm does not document all invalidated test results, test results that fail to meet licensed product specifications, and laboratory investigations of initial and retest out-of-specification test results. Also, it does not have SOPs that provide adequate instructions for situations that are encountered during routine HPLC setup, calibration, and use, etc. (licensed biological drug product Anascorp and its intermediates); FDCA 501(a)(2)(B), 21 CFR 211.113(b), 211.192, 211.165(f), 211.160(b), 211.25(a), 211.25(b), 211.25(c), 42(c), 211.111, 211.170(b), 211.125(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm394488.htm

Iowa Select Herbs, LLC Cedar Rapids, IA (4/18). Adulterated, misbranded: FDA’s review of product labeling on the firm’s Web site at www.iowaselectherbs.com has determined that Flax Seed, Holy Basil, Papaya Leaf Extract, and Ginkgo Leaf Extract products are promoted for conditions that cause them to be drugs. The firm failed to establish specifications for each component that it uses in manufacturing a dietary supplement. It also failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, etc. (herb products); FDCA 402(g)(1), 403(q)(5)(F), 21 CFR 111.70, 111.75(a)(1)(i), 111.95(b)(1), 111.73, 111.80(a), 111.155(c), 111.205(a), 111.103, 111.12(b), 111.120, 111.83(a), 111.27(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm394259.htm

Mar Cor Purification Plymouth, MN (4/17). Inspected 1/29-2/18. QSR deviations, adulterated, misbranded: The firm failed to adequately establish procedures for corrective and preventive action. It also failed to adequately establish procedures for receiving, reviewing and evaluating complaints by a formally designated unit. The firm failed to submit a written report to FDA of a correction or removal of a device, etc. (water purification systems: Millenium HX and Central Water System); FDCA 501(h), 502(t)(2), 21 CFR 820.100(a), 820.198(a)&(c), 820.40.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm394539.htm

River Hills Harvest dba Elderberrylife Hartsburg, MO (4/22). Inspected 11/18/13-1/24. Misbranded: The labeling for its “100% Pure Premium Elderberry Juice” promotes the product for conditions that cause the product to be a drug. (juice); FDCA 403(r)(1)(A), 403(i)(2), 21 CFR 101.30(b)(3), 101.12.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm394486.htm

Shasta Technologies, LLC Calistoga, CA (4/8). Inspected 12/2-9/13. QSR deviations, adulterated: No corrective and preventive action procedures were available for review upon request by the investigator. The firm failed to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met. It also failed to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, etc. (GenStrip Blood Glucose Test Strips); FDCA 501(h), 21 CFR 820.100(a), 820.198(a), 820.30(a), 820.50, 820.40, 820.20, 820.22, 820.181
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm392903.htm