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.
Chaotic Labz, Line One Nutrition, Inc., m4 Nutrition Companies LLC, NutraClipse, Inc., Swagger Supps, Total Body Nutrition, Xcel Sports Nutrition, LLC (3/31). Misbranded: The firms offer products which are labeled and/or offered for sale as a dietary supplement. The ingredient list on the product labeling declares methylsynephrine as a dietary ingredient. This ingredient is also called, among other names, Oxilofrine and p-hydroxyephedrine. FDA says methylsynephrine is not a dietary ingredient nor is it approved as a food additive, etc.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm494036.htm
Custom Compounding Center Little Rock, AK (3/16). Inspected 3/30-4/9/15. During this inspection, 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. CGMP violations, unapproved new drugs, misbranded: The firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination. It also failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions, etc. (drugs); FDCA 501(a)(2)(B), 21 CFR 211.113(b), 211.28(a), 211.42(c)(10)(iv), 211.166(a), 211.25(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm492685.htm
Kostechka Dairy, LLC Whitelaw, WI (3/28). Inspected 12/3 and 12/9/15. The dairy adulterated the new animal drugs (purged) (ceftiofur hydrochloride and (purged) lincomycin-spectinomycin. FDA’s investigation revealed that it did not use them as directed by their approved labeling or prescription label, which is an extralabel use. Also the dairy administered (purged) to its lactating dairy cows without following the animal class as stated in the prescription label. The extralabel use of (purged) was not under the supervision of a licensed veterinarian, etc. (dairy); FDCA 501(a)(5), 512(a)(4) and (5), 21 CFR 530.3(a), 530.41(a)(13)(ii).
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm493079.htm
Cheta Nand, MD Richland, WA (3/10). Investigated 10/6-10/30/15. Violations: The investigator failed to ensure that the investigation was conducted according to the investigational plan. For example, Protocol (purged) specified that subjects were to be treated with atorvastatin, simvastatin, or rosuvastatin, and that no dose should be lower than atorvastatin 20 mg, rosuvastatin 20 mg or simvastatin 40 mg. The investigator randomized subjects despite these subjects’ receiving a dose of simvastatin lower than 40 mg. For at least six weeks before screening, Subjects 1004, 1023, and 1037 were on stable doses of simvastatin 20 mg once daily. The investigator did not provide a corrective action plan that, if properly carried out, would prevent this type of violation in the future, etc. (drug study); 21 CFR 312.60
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm493102.htm
Alexander Neumeister, MD New York, NY (2/19). Inspected 7/16-8/5/15. Violations: The investigator failed to maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation. On worksheets for medical history, physical examinations, and neurological examinations, Neumeister personally hand-printed the name of the subinvestigator to indicate that these study procedures were conducted by the subinvestigator. However, Neumeister or another study employee actually conducted these study procedures, not the subinvestigator, etc. (drug study); 21 CFR 312.62(b), 312.60
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm493086.htm
The Wellness Pharmacy, LLC Winchester, VA (3/23). Inspected 3/9-12/15. During the inspection, the investigator noted that the pharmacy was not receiving valid prescriptions for individually identified patients for a portion of the drug products it was producing. Adulterated, misbranded: The firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions. It also failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes, etc. (compounded drugs); FDCA 501(a)(2)(A)&(B), 502(f)(1), 21 CFR 211.42(c)(10)(iv)&(v)&(vi), 211.113(b), 211.28(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm492676.htm