Latest FDA Warning Letters
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Horizon Pharmaceuticals Riviera Beach, FL (12/23/2016): FDA inspected the firm in 2015 and documented significant GMP violations for finished pharmaceuticals. The letter says the firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products. Additionally, the firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch, or any of its components, to meet any of its specifications. FDA recommends that the firm engage a consultant to assist it in meeting GMP requirements.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm536715.htm
Northern Health Products Loganville, GA (12/22): FDA reviewed the firm’s Web site (www.northernhealthproducts.com) and determined it markets unapproved products, including DCA Cancer Treatment Kit (sodium dichloroacetate and thiamine vitamin 81), ALA Alpha Lipoic Acid, N-A-C N-Acetyl L-Cysteine, DMSA Synergy, and DCA (sodium dichloroacetate).
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm536985.htm
Pharm D Solutions, Houston, Texas (12/8/2016): FDA inspected the firm in 2015 and observed serious deficiencies in its drug compounding practices for producing sterile drug products. For example, FDA says the firm used non-sterile disinfectants within the aseptic processing areas. In addition, it failed to demonstrate through appropriate studies that the hood is able to provide adequate protection of the ISO 5 area in which sterile products are produced.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm537064.htm
Sato Yakuhin Kogyo Co. Kashihara City, Japan (1/6): FDA inspected the firm 6/2016 and cited significant GMP violations for finished pharmaceuticals. For example, the letter says audit trails generated by the firm’s high-performance liquid chromatography (HPLC) system for impurities testing indicated that two tests for certain lots were conducted but data on the first testing were not maintained or available for inspection. The firm’s analysts told FDA that until the inspection they were permitted to perform repeat testing without scientific justification or documentation, and they said they were not required to maintain the data from the original results when performing investigations of system suitability failures, suspected errors, or out-of-trend results. FDA says that because the firm’s quality system does not adequately ensure the accuracy and integrity of data, a qualified consultant should be retained to assist in its remediation.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm536811.htm
Suzhou Pharmaceutical Technology Co. Jiangsu Province, China (1/6): FDA inspected the firm 6/2016 and documented GMP deviations. For example, FDA says the firm omitted the name and address of the original API manufacturer on the certificates of analysis (CoA) it issued to customers, and it did not include copies of the original batch certificate. It also generated CoAs by copying and pasting analytical results from the original API manufacturer and replacing the manufacturer’s information with its letterhead. Additionally, the letter says the firm has no quality unit. FDA recommends that the firm engage a consultant qualified to evaluate its operations and assist it in meeting GMP requirements.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm536866.htm