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

Allergan Medford, MD (5/29). Reviewed the firm’s Web site, http://www.seri.com. Adulterated, misbranded: The firm is marketing SERI Surgical Scaffold in the United States without marketing clearance or approval. (surgical scaffold); FDCA 515(a), 501(f)(1)(B), 502(o)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449569.htm

CK Management, Inc. Plano, TX (5/19). Inspected warehouse and distribution center located at 7 Sunset Way, Suite 140, Henderson, NV, where the firm’s products are received, stored, and distributed. FDA also reviewed Web sites at www.whole5.com, www.viaviente.com, www.fruitspirit.com, and www.fruitofthespirit.net in 11/2014 and in March. Unapproved new drugs, misbranded: The Web sites promote the products for conditions that cause the products to be a drugs. (Whole5, Fruit of the Spirit, and ViaViente); FDCA 403(r)(1)(A), 505(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm448810.htm

Colon Care Products of PA Barto, PA (5/28). Reviewed a video on the firm’s Web site: http://www.coloncareproducts.com/ and determined that the Colon Hydrotherapy Device is being marketed with general wellbeing and medical claims. A review of FDA records reveals that the firm has not received clearance or approval before offering this device for sale. (Colon Hydrotherapy Device); FDCA 502(o), 501(f)(1)(B), 510(k)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449801.htm

Heron Botanicals, Inc. Kingston, WA (5/28). Inspected 9/2-17/14. GMP deviations, adulterated, misbranded: Investigators observed that finished product specifications for identity, purity, strength, and composition were not established for the firm’s Echinacea angustifolia and Dipsacus sylvestris dietary supplement products. Also, the response is not adequate. The firm’s method for evaluating finished product purity does not ensure that the finished dietary supplement liquid extract is present in a certain percentage. On the label, the firm claims Echinacea angustifolia is extracted at 70%; however, there is no purity specification established for the dietary ingredient present in the finished product, etc. (dietary supplements); 21 CFR 111.70(e), 111.70(b)(1)&(2), 111.70(c)(1), 111.105(a), 403(e)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm450078.htm

I.V. Specialty, Ltd. Austin, TX (4/21). Investigators observed serious deficiencies in the firm’s practices for producing sterile drug products. CGMP deviations, adulterated, misbranded: Some of the facility’s drug products do not include the following information on the labeling: the lot or batch number and the statements, “This is a compounded drug”, “Not for resale”, and “Office Use Only.” The firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, etc. (compounded drugs); FDCA 502(f)(1), 505 http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449675.htm

Jian Peng Zhou Jlning, China (5/29). Reviewed the Web site, www.beautycosmeticstore.com. Adulterated, misbranded: The firm is marketing hyaluronic acid gel dermal fillers in the U.S. without marketing clearance or approval. (hyaluronic acid gel dermal fillers); FDCA 501 (f)(1)(B), 515(a), 502(o)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449545.htm

LifeCell Corp. Bridgewater, NJ (6/1). Reviewed the firm’s Web site http://www.lifecell.com/health-care-professionals/lifecellproducts/stratticetm-reconstructive-tissue-matrix/. The firm is marketing the Strattice Reconstructive Tissue Matrix in the U.S. without marketing clearance or approval. (Strattice Reconstructive Tissue Matrix); FDCA 502(o), 501(f)(1)(B), 515(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449737.htm

Medica Outlet Toronto, Canada (6/1). Reviewed the Web site, www.medicaoutlet.com. Adulterated: The firm is marketing various dermal fillers in the U.S. without marketing clearance or approval. (Teosyal products); FDCA 501 (f)(1)(B),
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449803.htm

Dr. Ashley Minas Minasian Medical Centre Sunik, Armenia (5/29). Reviewed Web site at www.consultdrminas.com. Adulterated, misbranded: The firm is marketing Interfall Hydrogel products, which are composed of 100% Polyacrylamide, and Teosyal products, which are composed of cross-linked and non-cross linked hyaluronic acid, in the U.S. without marketing clearance or approval. (Interfall Hydrogel and Teosyal); FDCA 502(o), 501(f)(1)(B)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449703.htm

Dr. Hettie Morgan San Diego, CA (5/29). Reviewed the firm’s Web site, www.hydrigelinjections.com, and determined that Interfall Hydrogel Injection is being marketed as a soft tissue filler for use “in the face, lips, and buttocks to increase their size and make them more aesthetically pleasing,” and for breast, genital, and whole body shaping. Adulterated, misbranded: The firm is marketing the device without clearance or approval. (Interfall Hydrogel Injection); FDCA 501(f)(1)(B), 515(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449730.htm

Nephros Inc. River Edge, NJ (5/27). Inspected 10/10-24/14. QSR deviations, adulterated: The firm failed to document the evaluation of potential suppliers. It also failed to include required information in its records of complaint investigations, etc. (Dual Stage Ultrafilter; Single Stage Ultrafilter, OLpur H2H Hemodiafiltration System; and OLpur Mid-Dilution Series Heinodiafiltration System); FDCA 501(h), 502(t)(2), 21 CFR 820.50(a)(1), 820.198(e). 803.52(b)(3)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm448879.htm

Ondamed Inc. Cornwall, NY (6/1). Adulterated: Reviewed the firm’s Web site, www.ondamed.net/us, and determined that it continues to market the Ondamed system as an unapproved biofeedback device. (Ondamed system); FDCA 501(f)(1)(B), 520(g), 502(o)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449578.htm

TEI Biosciences, Inc. Boston, MA (5/29). Reviewed the firm’s Web site http://www.teibio.com/products/by-brand/surgimend-prs/. Adulterated, misbranded: The firm does not have an approved PMA, IDE or 510(k) clearance for the device as described and marketed. SurgiMend is specifically indicated for: plastic and reconstructive surgery, muscle flap reinforcement, and hernia repair. The firm’s promotion of the device provides evidence that the device is intended for breast surgery applications, which would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval. (SurgiMend); 501 (f)(1)(B), 502(o)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449557.htm

Thorn Ford Dental Laboratory LLC Bothell, WA (6/2). Inspected 2/5-2/25. QSR deviations, adulterated: No corrective and preventive action procedures were available for review upon request by the investigator and the firm indicated that it has not established such procedures. The firm also has failed to establish complaint handling procedures. The firm failed to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, etc. (TAP 3 TL and Elite TL anti-snoring/obstructive sleep apnea devices and the Silent Partner anti-snoring/obstructive sleep apnea device); FDCA 501(h), 501(f)(1)(B), 502(o), 21 CFR 820.100(a), 820.198(a), 820.50, 820.80(d), 820.90(a), 820.22, 820.40, 803.17
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm450092.htm