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FDA Warning Letters: An Overview of 2019’s Letters So Far from freemexy's blog

The U.S. Food and Drug Administration (FDA) issues Warning Letters to biopharma, medical device and food companies when they find that a manufacturer has significantly violated FDA regulations. As of March 4, the agency issued 45 Warning Letters this year. Some are related to food companies, while quite a few are related to “vaping” products. Here’s a look at this year’s Warning Letters aimed at biopharmaceutical Noopept powder

Lymol Medical Corporation. Although somewhat outside the view of BioSpace’s coverage, it is mentioned here because it involves contamination of Sterile Talc Powder, which is an issue that has plagued Johnson & Johnson in recent years. The FDA issued a letter to Lymol on Jan. 8 related to lead content in talc.

Vitalab Pharmacy dba Vasco Rx. Vitalab was warned on Jan. 10 regarding “serious deficiencies in your practices for producing sterile drug products, which put patients at risk.” There appear to be issues with a laminar airflow hood design and poor aseptic technique on the part of technicians.

Vipor Chemicals Private. A Warning Letter was sent on Jan. 29 citing Vipor, located in India, with “significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients (API).” It also indicated one of the company’s suppliers, Basic Pharma Life Science Private (Ankleshwar, India) had been placed on FDA Import Alert 99-32 for refusing an FDA inspection on Oct. 10, 2017.

Hangzhou Sunking Nonwovens Co. The FDA issued a Warning Letter on Jan. 29 to China’s Hangzhou over an August 2018 inspection, citing several significant violations of CGMP regulations for finished pharmaceuticals.

New Era Naturals. Based in Durango, Colo., New Era received a Warning Letter after a March to April 2018 inspection, citing CGMP regulation violations for finished pharmaceuticals. In addition to not conforming to the CGMP regulations, the company’s “drug products are not listed with FDA as required by section 510(j) of the FD&C Act. Failure to properly list a drug product is prohibited and will render a drug misbranded.”

Green Water. Based in Conifer, Colo., Green Water was cited after a June and July 2018 inspection of its manufacturing facility. They were warned about serious violations of the Federal Food, Drug, and Cosmetic Act, specifically over unapproved new and misbranded drugs and issues with labeling.

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