Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Desert Rose Manufacturing, Inc. Anthony, NM (3/1). Inspected 7/10-12/12. GMP violations, adulterated, misbranded: The firm has no records of any specifications for the identity, purity, strength and composition of its raw materials such as vitamins, minerals, and botanicals that it uses in manufacturing nuphedrine, alfa PXP Plus, Lithium Orotate, zialipro and cleanseRX products. It has no records of any specifications for potential contaminants or limits for potential contaminants for nuphedrine, Lithium Orotate, cleanseRX II, and zialipro finished dietary supplements. Even though the firm receives a supplier’s certificate of analysis, it has not established specifications that the supplier must meet nor qualified the supplier, etc. (nuphedrine, alfa PXP Plus, Lithium Orotate, zialipro and cleanseRX products); FDCA 403(q)(5)(F), 21 CFR 111.70, 111.75, 111.105, 111.260, 111.80(c), 111.123(b)(2), 111.365(i), 111.605(a) and (b)
Electromedical Products International, Inc. Mineral Wells, TX (4/30). Inspected 1/28-2/1. QSR deviations, adulterated: The firm failed to establish procedures that clearly define the type and extent of control to be exercised over suppliers of products. For example, the firm’s Quality Manual section 7.4 “Purchasing” states suppliers will be reevaluated in the event of significant nonconforming product. It does not describe how significant nonconforming product will be defined to trigger a re-evaluation. Also, the inspection found three lots of contract manufactured devices in which the firm found many non-conformances, but it did not conduct a re-evaluation of its supplier, etc. (Alpha-Stim M; a microcurrent and cranial stimulator); FDCA 501(h), 21 CFR 820.50(a)(2), 820.100(a), 820.30(i)
Entrenet Nutritionals, Inc. Cuddy, PA (5/9). Inspected 10/12/12-11/1/12. GMP deviations, adulterated, misbranded: The product labels for the products Gone, Cardio Rescue, Arthri-Attack, and Complete Food Supreme are promoted for conditions that cause the products to be drugs. The company failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision. It also had no documentation of quality control operations related to approving for release, or rejecting, packaged and labeled Gone product for distribution, etc. (Gone, Cardio Rescue, Arthri-Attack, Complete Food Supreme, Purifying Cleanse I, Powerzyme, Seven Flowers BP, Radically Free); FDCA 502(f)(1), 505(a), 502(f)(1), 21 CFR 111.103, 111.140(b)(1), 111.127(h), 111.553, 111.475(b)(1), 101.4(h)(1), 101.9(b), 403(s)(2)(B), 403(q)(5)(F), 403(u), 403(q)(1)(B), 403(e)(1)&(2), 403(y)
Interlab S.r.l. Rome, Italy (2/28). Inspected 10/22-25/12. GMP deviations, adulterated: The firm failed to establish and maintain procedures to control device design to ensure that specified design requirements are met. It also failed to ensure that where the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedures, etc. (Class II non-sterile Immunofixation Electrophoresis Test using the Interlab G26 v2.0 Instrument in conjunction with Easy Mask antisera application device, Class I non-sterile Serum Protein Electrophoresis Test/Kit); FDCA 501(h), 21CFR 820.30(a), 820.75(a), 820.70(a), 820.198(a), 820.184, 820.22
Juve International LLC Draper, Utah (4/2). Reviewed the firm’s Web site, www.juve-international.com, and www.juvejuice.com. Misbranded: The Juve Juice product is promoted for conditions that cause the product to be a drug. For example, the Web site makes claims such as: “Reduce your blood pressure …, ” “Lower bad (LDL) cholesterol, ” and “… [R]educe your risk of cataracts,” etc. (Juve Juice); FDCA 505(a), 502(f)(1)
Rubimed AG Hergiswil, Switzerland (5/6). Inspected 1/28-29. GMP deviations, adulterated: The firm failed to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. It also failed to establish and maintain procedures for implementing corrective and preventive action. The firm’s complaint handling procedures do not include requirements to ensure that all oral complaints are documented upon receipt, that complaints are handled in a uniform and timely manner, and that all complaints are evaluated to determine whether the complaint should be filed as a Medical Device Report, etc. (REBA biofeedback device); FDCA 501(h), 21 CFR 820.30(a), 820.100(a), 820.198(a)&(b)&(e), 820.50(a)(2), 820.70(a), 820.180, 820.184, 820.22
Shippert Medical Technologies Centennial, CO (4/25). Inspected 1/9-11,14-16, 23, and 28. The firm could not provide documentation of validation for the sterilization process of the Tissu-Trans Filtron products or the injection molding process for the Tissu-Trans Filtron canisters. It also failed to establish a validation protocol that defined operating conditions and methods to ensure that design validation of the Tissu-Trans Filtron products conformed to user needs and intended uses, etc. (Lipoplasty Suction System units); FDCA 501(h), 21 CFR 820.75(a), 820.30(f)&(g), 820.30(g), 820.100(a), 820.50(a)(2), 820.80(a), 820.181, 820.30(e)
SmartPractice Denmark AS Phoenix, AZ. Reviewed promotional material 1/17. Misbranded: The firm’s promotional materials are false or misleading because they omit risk information. It failed to submit the promotional materials to CBER at the time of initial dissemination. The materials appear to have been disseminated without a package insert, etc. (T.R.U.E. TEST — Thin-Layer Rapid Use Epicutaneous Patch Test); 502(a) 201(n), 502(f)(1)
Weber Medical GmbH Lauenfoerde, Germany (5/2). Inspected 1/14-17. QSR deviations, adulterated: The FDA investigator reviewed the firm’s device history file for the Weberneedle product. The firm determined that a patient switch would mitigate risk pertaining to a timer failure, but the user manual has no instructions for use of the patient switch. The firm failed to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, etc. (Weberneedle); FDCA 501(h), 21 CFR 820.30(g), 820.50(a)(1), 820.50(a)(2), 820.184, 820.80(d), 820.72(a), 820.30(f).