Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Abco Laboratories Fairfield, CA (6/19). Inspected 8/26/11-9/9/11. Unapproved new drug, misbranded: The labeling on Ibu-Relief 12 makes claims such as “pain relief” that make the product a drug. Drug products intended for the indication such as that for which Ibu-Relief 12 is labeled are being evaluated under the Tentative Final Monograph for GTC External Analgesics, which did not include either the ingredient ibuprofen or arnica montana,1 nor were these ingredients evaluated as part of the OTC drug review for any external use Although arnica montana is an established homeopathic active ingredient, ibuprofen is not a recognized active ingredient in the Homeopathic Pharmacopeia of the U.S. or any of its addenda or supplements. FDA adds that ibuprofen is not listed in any recognized materia medica containing information on the preparation of homeopathic medicines and is therefore not a homeopathic ingredient, and "Ibu-Relief 12" is not considered a homeopathic drug product under the CPG. Also, the product Sexual Virility Max contain structural analogs of sildenaftl. Sildenaftl citrate is an active pharmaceutical ingredient , etc. Ibu-Relief 12, Sexual Virility Max); FDCA 505(a), 403(r)(6), 502(f)(1) 502(a) (FEI # 1000142677)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm309170.htm
Arrowhead Medical Device Technologies Collierville, TN (5/18). Inspected 2/13-16 and 21. QSR deviations, adulterated: The firm failed to adequately validate with a high degree of assurance and approve according to established procedures, a process that cannot be fully verified by subsequent inspection and test. It also failed to establish and maintain procedures defining the responsibility for review and authority for disposition of nonconforming product, etc. (orthopedic products for reconstructive surgery of toes and surgical instruments for implanting orthopedic products); FDCA 501(h), 21 CFR 820.75(a), 820.90(b)(1), 820.100(a), 820.30, 820.80(a), 820.198 (2012-NOL-21)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm309114.htm
Covidien, Inc. Mansfield, MA (6/14). Inspected 1/13-2/9. QSR deviations, adulterated: Despite receiving numerous complaint, adverse event, and serious adverse event information since 5/2009 on the use of the DUET TRS, a CAPA investigation was not initiated until 1/19 and after the FDA inspection team requested to review the CAPA file related to these complaints and adverse events. The firm has received reports of deaths and serious injuries associated with the use of the DUET TRS Reload since 2009, as shown in the firm’s monthly tracking graphs. The firm failed to document investigations into deaths and serious injuries that resulted in issuance of a Safety Alert for use of the DUET TRS Reload in Japan in 3/2011, etc. (surgical staples and single-use loading units, such as the DUET Tissue Reinforcement System, Reload); FDCA 501 (h), 21 CFR 820.100(a), 820.198(d) (CMS#282277)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm309106.htm
Family Beginnings, PC Indianapolis, IN (6/15). Inspected 5/1-8. HCT/P deviations: The firm failed to test a specimen from an anonymous or directed reproductive donor of cells and tissue, whether viable or nonviable, for evidence of infection due to relevant communicable disease agents. It also failed to determine as ineligible, a donor who has risk factors for, or clinical evidence of, relevant communicable disease agents or diseases, etc. (human cells, tissues, and cellular and tissue-based products); 21 CFR 1271.85(a)&(b)&(c), 1271.75(a)&(d), 1271.80(b) (2012-DET-19)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm309023.htm
Grimm Scientific Industries Marietta, OH (6/19). Inspected 2/27-3/2. Unapproved devices, QSR deviations, adulterated: There is no written finished device acceptance procedure for the CRYOTherm, single or dual, hydrotherapy device. A total of 3 out of 12 acceptance records reviewed for the CRYOTherm devices had an out-of-specification psi for adjusting the superheat; and one of the 12 did not have testing documented. However, these were not handled as non conformances and were still distributed. The “Customer Complaint Procedure” dated 11/20/09 does not address investigating complaints involving the possible failure of a device, etc. (CRYOTherm device); FDCA 501(f)(1)(B), 515(a), 502(o), 501(h), 502(t)(2), 21 CFR 820.80(d), 820.90(a), 820.100(a), 820.30(i), 820.170(a), 820.198(c), 820.80(b), 820.22, 803.17 (CIN-12-296678-24)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm309060.htm
Nevyas Eye Associates Bala Cynwyd, PA (6/5). Inspected 3/19-28. Misbranded: The firm failed to develop, maintain, and implement written MDR procedures. Its response is not adequate because it ate did not include a copy of its MDR procedures, etc. (ophthalmic laser used to perform LASIK); FDCA 502(t)(2), 21 CFR 803.17 (No code)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm309355.htm
Oertel Medical GmbH Tuttlingen, Germany (6/11). Inspected 1/25-27. QSR deviations, adulterated: The firm failed to establish and maintain adequate procedures for implementing corrective and preventive action. Review of five CAPA Form 8-D reports out of 11 disclosed that the documentation of correction and preventive actions was incomplete. The firm also failed to establish and maintain procedures for rework, to include retesting and reevaluation, of non-conforming product after rework to ensure that the product meets its current approved specifications, etc. (non-powered endoscopic grasping/cutting instruments); FDCA 501(h), 21 CFR 820.100(a), 820.100(b), 820.198(a)&(b)&(e), 820.90(b)(2), 820.70(i), 820.75(a), 820.50, 820.40, 820.181(b), 820.184, 820.25(b) (No code)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm309306.htm
Shamrock Medical Solutions Group, LLC Lewis Center, OH (6/15). GMP deviations, adulterated: Repackaging technicians changed master labels of repackaged products, which resulted in product packages labeled with incorrect strength or incorrect spelling of the drug name. The firm then released these mislabeled drug products for distribution. The firm does not have any written procedures for the manual repackaging of liquid drugs into oral syringes or fluid dose cups and thus does not have a process to ensure that the repackaged containers are properly filled, etc. (finished pharmaceuticals); FDCA 502(b)(2), 21 CFR 211.68(b), 211.100(a), 211.22(d), 211.188 (CIN-12-232619-23)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm309300.htm
Stingray Surgical Products, LLC Boca Raton, FL (5/3). Inspected 11/30-12/5/11. Adulterated: The firm’s validation of its coating process is inadequate in that it failed to demonstrate consistency of the coating process because it only included one device, it only tested the coating integrity and not coating adhesion or thickness, and it failed to document any parameters used for the coating process, etc. (electrosurgical forceps); FDCA 501(h), 21 CFR 820.75(a), 820.70(a)&(b), 820.80(b), 820.50, 820.198(b), 820.22 (FLA-12-32)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm309452.htm
Testing Center of Sanitation and Environment Technic Institute Suzhou, China (10/13/11). Inspected 5/30-6/3/11. Violations: The study director failed to assure that each study has an approved written protocol and fulfill his/her responsibilities. The center also failed to prepare an adequate final study report. The quality assurance unit failed to maintain a master schedule sheet and to prepare and sign the final study report statement, etc. (nonclinical lab studies); 21 CFR 58.33(a) and (f) and 58.120, 58.185, 58.35(b)(1) and (7), 58.81(a), 58.51, 58.45, 58.63(a) (No code)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm309508.htm
