Latest FDA Warning Letters
FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Infusion Systems of SW Florida Inc., dba Myerlee Pharmacy Fort Myers, FL (2/3). Inspected 12/1-22/14. GMP violations, adulterated: The firm was not receiving valid prescriptions for individually identified patients for a portion of the drug products it was producing. The investigator also observed an operator with exposed forearms and operators resting their forearms inside the ISO 5 areas (laminar flow hoods) during aseptic processing for sterile drug products. Also, personnel did not sanitize the component bags (e.g., bags containing vials, syringes and filters) with (purged) prior to placing them inside the ISO 5 areas, etc. (sterile drugs); FDCA 501(a)(2)(A)(B), 502(f)(1), 21 CFR 211.113(b), 211.42(c)(10)(iv)(v), 211.28(a), 211.167(a), 211.165(a), 211.166(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm486700.htm
OPS International Inc., dba Olympia Pharmacy Orlando, FL (2/4). Inspected 11/17-21/14. CGMP violations, adulterated, unapproved new drugs, misbranded: The investigator observed poor aseptic practices that would not provide adequate protection of sterile drug products in the ISO 5 area, including processing sterile drug products in a laminar flow hood that was not turned on. FDA notes that Olympia Pharmacy has a history of poor sterile practices. The facility failed to submit a report to FDA upon registering as an outsourcing facility in 3/2014, identifying the drug products that it compounded during the previous six-month period. Some of the facility’s drug products do not include the following on the label: the established name of the drug, the statement of volume, the statements, “This is a compounded drug” and “Not for resale,” and for drugs dispensed or distributed other than pursuant to a prescription for an individual identified patient, the statement “Office Use Only,” etc. (sterile drug products); FDCA 503B(b), 501(a)(2)(A)(B), 505(a), 502(f)(1), 21 CFR 211.42(c)(10)(vi), 211.113(b), 211.42(b), 211.42(c)(10)(iv), 211.165(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm486673.htm
Gregory J. Tracey, MD Hoboken, NJ (12/16/15). Inspected 3/25-4/15/15. Clinical investigator violations: The investigator failed to ensure that the investigation was conducted according to the investigational plan. For example, the investigational plan for Protocol (purged) requires that the investigator verify that study subjects meet all eligibility criteria, and, in particular, that he doesn’t include subjects with a positive serum pregnancy test at screening or at check-in. The investigator failed to adhere to these requirements. The response is inadequate because the corrective action plan is not sufficiently detailed. The investigator enrolled Subject 1214 despite the reference range for serum hCG on the laboratory reports clearly stating that any values above 5.2 mIU/mL are indicative of pregnancy, but he did not provide details on the laboratory’s plan to use new procedures, or specifics on the steps that he and his colleagues will take to ensure the appropriate review of the laboratory’s reports and the enrollment of eligible subjects, etc. (investigational study); 21 CFR 312.60
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm487077.htm