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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.

86 Harriet Ave. Corp. dba General Devices Ridgefield, NJ (6/1). Inspected 6/2/15-6/11/15. QSR deviations, adulterated: The firm failed to adequately establish procedures for corrective and preventive action and to adequately establish design change procedures. It also failed to establish an internal system which provides for the timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, etc. (Carepoint EMS WorkStation/GEMS Series 4000, ElM­ lOS Prep-Check, EIM-107-20A Prep-Check Plus, Rosetta-Lt, and Rosetta-Rx); FDCA 501(h), 21 CFR 820.100(a), 820.30(i), 803.17(a)(1)


Florida Institute for Reproductive Sciences and Technologies Weston, FL (4/12). Inspected 1/11-1/22. Deviations from regulations for human cells, tissues, and cellular and tissue-based products: There is no documentation on file that a donor eligibility determination was made by the responsible person for directed semen donors. Donors were determined eligible before communicable testing results were received. The facility also failed to screen a donor of reproductive cells or tissue by reviewing the donor's relevant medical records for risk factors for and clinical evidence of relevant communicable disease agents and diseases, etc. (human cells, tissues, and cellular and tissue-based products); 21 CFR 1271.50(a), 1271.75(a)(1), 1271.85(a) and (b)(1), 1271.80(b)


Hollywood Skincare International, Inc. Hollywood, FL (4/14). Reviewed Web site at http://www.dermasetskin.com/ in February. Unapproved new drugs. The claims on the Web site establish that DermaSet Stem Cell 3D Renewal Treatment is a drug. For example, the site claims: “Removes Wrinkles Instantly” and for the Sea Fennel Stem Cell it claims: “The Sea Fennel stem cell has the effect of lightening the skin…,” etc. (DermaSet Stem Cell 3D Renewal Treatment) FDCA 505(a)


KO DA Pharmaceutical Co. Taoyuan City, Taiwan (5/27). Inspected 5/25-27/15. GMP deviations, adulterated: The firm’s quality control unit failed to approve or reject all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product. It also failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and released for use by the quality control unit, etc. (finished pharmaceuticals); FDCA 501(a)(2)(B), 21 CFR 211.22(c), 211.100(a), 211.84(a), 211.186(a)


Liberty Drug and Surgical Chatham, NJ (3/14). Inspected 3/30-5/22/15. Violations: The investigators noted that the firm was not receiving valid prescriptions for individually identified patients for a portion of the drug products it was producing. Investigators also observed component bags cleaned with non-sterile wipes in an unclassified room, then transferred to the ISO 7 anteroom and placed on a potable water sink, before being transferred to the ISO 5 area with no additional disinfection steps. Also, the operators were observed following poor aseptic practices such as using non-sterile lint-free wipes within the ISO 6 clean room, ISO 5 hoods, and on products that are stored out of their original containers on a supply wire cart, etc. (pharmaceuticals); FDCA 501(a)(2)(A), 505(a), 502(f)(1), 21 CFR 211.113(b), 211.166(a), 211.167(a)


RXQ Compounding LLC Athens, OH (5/19). Inspected 8/24/15-9/21/15. Violations, adulterated, misbranded: The investigators noted that drug products that are intended or expected to be sterile were prepared, packed, or held under unsanitary conditions whereby they may have been contaminated with filth or rendered injurious to health, causing them to be adulterated. The containers for some of the facility’s drug products did not include information to facilitate adverse event reporting. The facility failed to submit a report to FDA upon registering as an outsourcing facility in 1/2015, identifying the drug products that it compounded during the previous six-month period, etc. (finished pharmaceuticals); FDCA 501(a)(2)(A)(B), 505(a), 502(f)(1), 21 CFR 211.42(c)(10)(iv)&(vi)), 211.113(b), 211.167(a)), 211.22(c))


Spectranetics Corp. Colorado Springs, CO (5/23). Inspected 11/30/15-1/21. QSR deviations, adulterated: The firm failed to validate a process whose results cannot be fully verified by inspection and test. For example, the firm has not validated the (purged) process used to manufacture part of the outer jackets subassembly of both its Class 3 GlideLight and SLS Laser Sheath finished devices (sizes 12F, 14F, and 16F) (purged) and are used for pacemaker and defibrillator lead removal in conjunction with the Excimer Laser System. This laser system includes a Class IV laser and part of the function of the outer jackets is to house and contain the laser. Complaints have been reported for failures such as cracks, splits, damage to the outer jacket and / or sparks and visible laser light through the outer jacket. Also, the firm’s Risk Management Overview procedure states risk management documents should be continually reviewed and updated as new information becomes available, including information from (purged). This procedure has not been adequately implemented, etc. (lead management disposable catheter lines including laser sheath device products, specifically the GlideLight and the SLS II sheaths); FDCA 501(h), 21 CFR Part 820.75, 820.30, 820.100, 820.22, 1010.2(c), 1002.20, 1002.11, 1003.11(b)

Ultimate Weight Loss Co. Orlando, FL (4/14). Reviewed Web site at www.zxtbeepollenpills.com. Unapproved new drugs, misbranded: FDA confirmed through laboratory analysis that the firm’s “Jenesis,” “Prime,” and “Propell Platinum” contain undeclared sibutramine and phenolphthalein. The products “Jenesis,” “Prime,” and “Propell Platinum” are articles (other than food) intended to affect the structure or function of the body and, thus, are drugs. For example, claims made on the product label for Jenesis are: “Suppresses Appetite,” “Increased Energy and Accelerate Fat loss,” etc. (Jenesis, Prime, and Propell Platinum); FDCA 502(f)(1)(2), 502(a)