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

BioLab-St. Joseph Corp. Bayamon, Puerto Rico (3/18). Inspected 8/6/14-8/27/14. QSR deviations, adulterated, unapproved device: The firm failed to establish and maintain procedures for implementing corrective and preventive action. The firm has not established procedures to ensure that products received from suppliers and services are acceptable for their intended use. The requirements that must be met by suppliers, contractors, and consultants have not been defined and documented, etc. Also, investigators found that the Muller Hinton Agar, Mueller Hinton Blood, and Thayer-Martin Agar are adulterated because the firm does not have an approved application for PMA or IDE. They are misbranded because the firm has not notified FDA of its intent to introduce them into commercial distribution. (microbiology culture media for in vitro diagnostic testing); FDCA 501(h), 501(f)(1)(B), 502(o), 510(k), 21 CFR 820.100(a), 820.75(a), 820.50, 820.80(b), 820.198(e), 827.70(c), 820.22, 820.25(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm450839.htm

CooperSurgical, Inc. Trumbull, CO (6/9). Inspected 11/14-12/17/14. Unapproved device, adulterated, misbraned: The Infant Heel Warmer, originally named Instant Warm Gel Pack, was cleared under K912715 to provide heat therapy, but not for use on infants. The firm’s supplemental information submitted to FDA on 9/25/91 did not convey that this device was to be used on infants. The firm has renamed the Instant Warm Gel Pack as Infant Heel Warmer and promoted it for use in providing warmth to increase blood flow and enhance infant blood sample collection. (Infant Heel Warmer); FDCA 502(o), 510(k), 515(a), 502(t)(2), 21 CFR 803.50(a)(2).
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm451042.htm

Green Hills Health and Wellness Pharmacy, Inc. dba Health and Wellness Compounding Pharmacy Nashville, TN (6/4). Inspected 10/14-22/14. Unapproved new drugs, misbranded: During the FDA inspection, the investigators observed that the firm does not receive valid prescriptions for individually identified patients for a portion of the drug products it produces. Labeling fails to bear adequate directions for use. The firm also failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. The firm’s planned corrective actions, as documented in its 11/11/14 response to the FDA-483 issued at the close of the inspection and determined that they are inadequate to correct the observed insanitary conditions at the facility, etc. (drug products); FDCA 501(a)(2)(A), 505(a) and 502(f)(1).
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm450682.htm

MedsIndia Ltd. (6/8). Reviewed Web sites such as www.antianxietymedicationsnow.com and determined that they offer products for sale in violation of the FD&C Act, which are unapproved and misbranded. Many products offered for sale on the Web sites are indicated to treat serious medical conditions for which supervision by a licensed healthcare practitioner is necessary to ensure safe and effective use. The Web sites offer “Generic Nolvadex” and claim that is “used for treating breast cancer that has spread to other sites in the body” and that, “[i]t is used in women who are at high risk for breast cancer and in women with DCIS to decrease the risk of developing breast cancer.” The agency says there are FDA-approved generic versions of FDA-approved Nolvadex, but there is no FDA-approved drug application for “Generic Nolvadex,” and as such, it is an unapproved new drug product. The Web sites also offer misbranded drugs containing isotretinoin, which is legally marketed under other approved applications, but it is restricted to a distribution program called a Risk Evaluation Mitigation Strategy, etc. (Nolvadex, Meridia, Generic Valium, Generic Xanax, etc.); FDCA 505(a), 503(b)(1)(B)(iii), 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm450540.htm

Insulet Corp. Billerica, MA (6/5). Inspected 3/11-27. QSR deviations, adulterated: The firm released five lots of EROS OmniPods that failed release testing and were released through a nonconformity review despite all lots falling below the firm’s quality assurance final acceptance criteria. The 4/16 response is not adequate, etc. (OmniPod Insulin Management System); FDCA 501(h), 21 CFR 820.90(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm451037.htm

Rx Partners (6/8). Reviewed Web sites such as www.cheapestonlinedrugstore.com and genericcialisonlinedt.com. Unapproved new drugs (Generic Truvada, Generic Advair Diskus, Generic Depakote)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm450541.htm

Total Health Advanced Nutrition, Inc. Columbia Heights, MN (5/29). Inspected 10/28-29 and 11/3/14. GMP deviations, adulterated: The firm failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the EDTA Oral Chelation Nuvi-Detox dietary supplement that it manufactures, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of dietary supplement. Also, the firm failed to establish specifications for the Nuvi-JointRx dietary supplement it receives from a supplier for labeling as a dietary supplement to provide sufficient assurance that the product it receives is adequately identified and is consistent with the purchase order, etc. (NutrivityRX, namely, EDTA Oral Chelation Nuvi-Detox and Nuvi-JointRx.); 21 CFR 111.70(b)(1)(2)&(e)&(f), 111.75(c), 111.255, 111.103, 111.55, 111.410(d), 111.453, 111.403, 111.553\
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm450169.htm