FDA Warning Letters: An Overview of 2019’s Letters So Far

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freemexy

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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
companies.buy 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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