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.
alvSupplement Direct dba TJM Resale’s Synaptik Supplements & Ligand Solutions Saint Paul, MN (3/3). Reviewed the label for “Anhydrous Caffeine Bulk Powder” product. Also, in January FDA reviewed the firm’s Web site at www.alvSupplementdirect.com (which redirects to www.synaptiksupplements.com). Unapproved new drug, adulterated dietary supplement, misbranded: The claims on the Web site establish that “Anhydrous Caffeine Bulk Powder” is a drug, etc. (Anhydrous Caffeine Bulk Powder); FDCA 505(a), 502(f)(1), 402(f)(1)(A)(i)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm489374.htm
Diversified Pharmacy, Inc., dba University Compounding Pharmacy Troy, MI (2/26). Inspected 10/29-11/13/14. Investigators noted that the firm was not receiving valid prescriptions for individually identified patients for a portion of the drug products it was producing. Also, they observed that the firm produces domperidone products. GMP deviations, adulterated, misbranded: The firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. It also failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination, etc. (drug products); FDCA 501(a)(2)(A)(B), 502(f)(1), 21 CFR 211.113(b), 211.42(c)(10)(iv)(v), 211.28(a), 211.166(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm490059.htm
Emcure Pharmaceuticals Ltd. Maharashtra, India (3/3). Inspected 1/27-2/4/15. GMP deviations, adulterated: FDA investigators observed poor aseptic processing techniques during the manufacture of (purged) injection USP (aseptically filled for U.S. market) batch. For example, operators crawled on the floor on their hands and knees under the filling line during routine aseptic filling operation activities. Collecting (purged) water from the bottom of the filling machine to lubricate equipment also raises concerns about the design and qualification of the firm’s equipment, etc. (finished pharmaceuticals); FDCA 501(a)(2)(B), 21 CFR 211.113(b), 211.160(b), 211.194(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm489735.htm
High Hopes Farms, PTSP Chestertown, MD (3/8). Inspected dairy farm 12/9 and 12/11/15. Adulterated: The inspection revealed that the farm did not use Albon as directed by its approved labeling. It administered Albon (sulfadimethoxine, 5g bolus, NADA #31-715) to a bob veal calf without following the animal class as stated in the approved labeling. Use of this drug in this manner is an extra label use and was not under the supervision of a licensed veterinarian, etc. (Albon); FDCA 50l(a)(5), 21 CFR 530.1l(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm489965.htm
Innovative Sterilization Technologies, LLC Dayton, OH (3/2). Inspected 8/4-13/15 and 10/6-11/4/15. GMP deviations, adulterated: The firm failed to establish and maintain procedures for implementing corrective and preventive actions. The Corrective and Preventive Action procedures dated 12/22/14 do not address analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product or other quality problems. The procedures also do not address employing appropriate statistical methodology, where necessary, to detect recurring quality problems. Also, the firm failed to establish and maintain a Design History File for each type of device to demonstrate the device was developed in accordance with the approved design plan, etc. (specification developer of the ONE TRAY Sealed Sterilization Container); FDCA 501(h), 502(t)(2), 21 CFR 820.100(a), 820.30(a)(1), 820.198(a), 820.70(b), 820.50
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm489358.htm
SureTek Medical Greenville, SC (3/3). Inspected 10/26-11/10/15. GMP deviations, adulterated: The firm’s validated cleaning process is not routinely monitored to assess contamination levels for reprocessed single-use devices subjected to the process. The most recent assessments for contamination were performed in 2012 as part of Cleaning Validation of Compressed Sleeves, Protocol #12019 (for hemoglobin and bioburden) and Cleaning Validation of Orthopedic, ENT and Laparoscopic Instruments, Protocol #12020-A (for hemoglobin and protein). The firm’s response letters fail to adequately address the validity of the statistical techniques used for selecting the number of samples for testing during the cleaning validation studies performed, etc. (orthopedic and laparoscopic instruments); FDCA 501(h), 21 CFR 820.75(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm489979.htm