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

Ad-Med Biotechnology, LLC A.M.S. Bioteck, LLC Birmingham, MI (8/12). Unapproved new drugs, misbranded: The firm’s Web sites and the product label for Immune Active Adult Formula and Immune Active Children’s Formula promote the products for conditions that cause them to be drugs. (Immune Active Adult Formula and Immune Active Children’s Formula); FDCA 403
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410476.htm

Big Easy Confections, LLC Covington, LA (8/14). Inspected 5/5-14. GMP deviations, adulterated, misbranded: The firm manufactures dietary supplements and accepts and uses components based on a certificate of analysis from the supplier without performing any identity tests. The firm failed to establish required specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of its product and that it is packaged and labeled as specified in the master manufacturing record, etc. (dietary supplements); FDCA 402(g)(1), 21 CFR 111.75(a)(1)(i) & (a)(2)(ii)(A), 111.70(a), 111.95(b), 111.205(a), 111.255(a), 111.103, 111.155(c), 111.403.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410864.htm

Calaire Chimie SAS Calais Cedex, France (7/18). The owner of the facility has failed to pay the appropriate facility fee as required by the Generic Drug User Fee Amendments of 2012. (drug products); FDCA 379j-41to 379j-42.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410032.htm

Children’s Medical Ventures/Philips Healthcare Andover, MA (8/8). Inspected firm previously located at 191 Wyngate Drive, Monroeville, PA 3/10-3/28. QSR deviations, adulterated: The firm failed to establish and maintain procedures to control product that does not conform to specified requirements. Complaint files are not adequately maintained. The firm’s SmartMonitor 2 PS devices and/or SM2PS battery pack replacement components were found to have a wiring issue resulting in device failures causing the units to constantly alarm, not allowing continuous monitoring of respiration, heart rate, and oxygen saturation of infant patients, as intended. A field change order documents a retrofit on failure field correction is instructed to be performed on all affected units, which was not reported in writing to FDA, etc. (SmartMonitor 2 PS); FDCA 501(h), 502(t)(2), 21 CFR 820.90 (a), 820.198 (a), 806.20(b)(5)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410917.htm

Colgate Oral Pharmaceuticals Inc. Dallas TX (8/8). The owner of the facility has failed to pay the appropriate facility fee as required by the Generic Drug User Fee Amendments of 2012. FDCA 379j-41(5)(A)(i)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410876.htm

The Compounding Shop, Inc. St. Petersburg, FL (8/12). Inspected 3/18-22/13 and 3/22-9/3/13. GMP violations, adulterated: 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 noted that the firm continues to make domperidone drug products, despite having received prior warnings in an Untitled Letter issued on 3/17/05 and a second letter dated 5/3/05. Also, serious deficiencies were observed in the firm’s practices for producing sterile drug products, such as facility-dedicated clothing, which aseptic technicians wear under reusable sterile gowns, was stored on an open shelf a few feet from the toilet in the restroom, etc. (drug products); FDCA 503A(b)(1)(A)(i), 502(f)(1), 502(a), 501(a)(2)(A), 21 CFR 211.113(b), 211.166(a), 211.167(a), 211.42(c)(10)(iv), 211.28(a), 211.165(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410634.htm

EnerHealth Botanicals, LLC Longmont, CO (8/8). Inspected 7/9,10, and 7/12/13. Unapproved new drugs, adulterated, misbranded: Products are promoted for conditions that cause them to be drugs, etc. (Parasite Purge Herbal Remedy, Black Walnut Extract, Bladder Cleanse Herbal Extract, Lung Renewal Herbal Remedy, and Daily Immune Support); FDCA 505(a), 402(g)(1), 21 CFR 111.75(a)(1)(i), 111.70, 111.140(b)(1), 111.205(a), 111.210(h), 111.260(b), 111.83(a), 111.403, 111.453, 111.553, 111.503
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410131.htm

Explora Laboratories SA Mendrisio 6850 Switzerland (8/7). The owner of the facility has failed to pay the appropriate facility fee as required by the Generic Drug User Fee Amendments of 2012. FDCA 379j-41(5)(A)(i)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410062.htm

Human Science Foundation Gardena, CA (8/18). Inspected 1/8-1/16. Unapproved new drugs, misbranded: FDA laboratory analyses confirmed the following undeclared ingredients in the firm’s distributed products: Pro ArthMax — chlorzoxazone, diclofenac, indomethacin, ibuprofen, naproxen, and nefopam and in Super Arthgold — chlorzoxazone, diclofenac, and indomethacin. Chlorzoxazone is the active pharmaceutical ingredient in the FDA-approved drug Parafon Forte DSC, a prescription drug used to relieve musculoskeletal pain. Diclofenac, indomethacin, ibuprofen, and naproxen are non-steroidal anti-inflammatory drugs and APIs found in FDA-approved drugs that are used to treat pain and inflammation. (ArthMax and Super Arthgold); FDCA 502 and 503(b)(1)(A)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410651.htm

Korea United Pharm Inc. Yeonseo-myeon Sejong-si, Korea (8/7). The owner of the facility has failed to pay the appropriate facility fee as required by the Generic Drug User Fee Amendments of 2012. FDCA 379j-41(5)(A)(i)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410040.htm

Masimo Corp. Irvine, CA (8/12) Inspected 8/13-10/3. QSR deviations, adulterated: Multiple complaints of device failures were not adequately reviewed, evaluated, and investigated. The records of investigations did not contain required information regarding the nature and details of the complaint, etc. (Rainbow SET Pronto-7 Pulse CO-Oximeter and Rad-8 Signal Extraction Pulse Oximeter); FDCA 501(h), 21 CFR 820.198(c)&(e), 820.100(a)(3), 820.100(a)(2)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410636.htm

Pharma Tech Solutions Westlake Village, CA (7/7). Inspected 3/4-6. QSR deviations, adulterated: The firm could not provide any corrective and preventative action procedures or files for review. Also, records of complaint investigations do not include required information, etc. (GenStrip glucose test strips); FDCA 501(h), 502(t)(2), 21 CFR 820.100(a), 820.198(e)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410865.htm

Simply Clean Air & Water Inc. Newington, CT (8/18). Inspected 7/9-7/18. QSR deviations, adulterated: The firm does not have any design control procedures in order to ensure that specified design requirements are met. The firm’s PEDI systems provide water for hemodialysis applications and are labeled to meet the requirements of an outdated standard. The firm did not provide any documentation that the PEDI systems have undergone testing to demonstrate the devices meet the requirements of the current standard, nor has any testing been performed, etc. (Portable Exchange Deionization systems); FDCA 501(h), 21 CFR 820.30(g), 820.80(a), 820.50, 820.184(d)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410467.htm

Suzuken Co. Ltd. Oguchi Center Nagoya, Aichi, Japan (6/11). Inspected 1/27-1/30. QSR deviations, adulterated: The firm failed to establish procedures for assuring that problems that were identified as needing corrective actions were fully investigated; appropriate corrective actions were identified and implemented; and those corrective actions were verified. For example, seven CAPAs, opened between 10/26/12-10/21/13 did not include any actions to correct the identified issues. This is a repeat observation from the previous inspection. The firm’s equipment purchasing procedure does not ensure that equipment used to test finished devices is calibrated properly, etc. (Holter ECG monitoring medical devices and electrodes); FDCA 501(h), 21 CFR 820.100(a).), 820.198(a)&(c), 820.72(a).
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410029.htm

Vention Medical Barreal de Heredia, Costa Rica (7/1). Inspected 3/3-6. QSR deviations, adulterated: The firm has not validated in-house test methods for maintaining the cleanliness of the controlled environment. Also, the firm failed to establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met, etc. (thermotherapy systems, cord blood processing systems, negative pressure wound therapy equipment, and various types of catheters); FDCA 501(h), 21 CFR 820.75(a), 820.70(c), 820.70(g)(1), 820.100(a)&(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410035.htm

Zion Rx Formulations Services, LLC Mesa, AZ (8/15). Inspected 12/3/13-1/9. GMP violations, adulterated, misbranded: The investigators observed serious deficiencies in the firm’s practices for producing sterile drug products: FDA tested and confirmed that environmental samples collected in the facility tested positive for numerous gram-negative bacteria and spore-forming microbes, including fungi. Also investigators observed operators processing sterile drug products with exposed skin on their faces. The firm does not use sporicidal agents to clean the production areas, only infrequently performs viable and non-viable monitoring, and does not monitor pressure differentials throughout the day, especially during periods of production, etc. (drug products); FDCA 501(a)(1)&(2)(B), 502(f)(1), 21 CFR 211.42(c)(10)(iv), 211.113(b), 211.167(a), 211.28(a), 211.42(c)(10)(vi), 211.166(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410730.htm