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

white pills in factory

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.

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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Actavis Laboratories FL. This Davie, Fla.-based company was cited after a July 2018 FDA inspection for CGMP regulations for finished pharmaceuticals. There were issues with adequate written procedures, issues with tablet manufacturing validation, largely around a laser-drilling tablet manufacturing process.

Akorn. The FDA issued a Warning Letter to this Lake Forest, Ill.-based company after an April and May 2018 inspection for CGMP violations. Some of the problems regarded microbial contamination of drug products and aseptic technique by employees. There were also issues related to contaminated materials in the company’s cleanroom.

Blue Ridge Silver. Based in Blowing Rock, NC, Blue Ridge Silver was warned by the FDA over its Colloidal Silver Products, largely over false and misleading statements about the products on the company’s website and marketing materials.

Peak Nootropics (aka Advanced Nootropics). The FDA issued a letter on Feb. 5 over false claims on its website. The agency stated, “Your products Adrafinil, Aniracetam, Bacopa Monnieri, L-Dopa, L-Theanine, Noopept, Oxiracetam, Phenibut, Phenylpiracetam, Piracetam, Pramiracetam, Rhodiola Rosea, and Uridine are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are ‘new drugs’ under section 201(p) of the Act.”

Emmbros Overseas Lifestyle PVT. This India-based company was also cited on Feb. 5 for false claims on its website and violations of the Act.

DK Vitamins. Located in Palm Bay, Fla., DK Vitamins was yet another mail order company making false claims on its website and in marketing materials over some of its product. Other companies on the same day that were issued similar Warning Letters include Earth Turns, Sovereign Laboratories, Gold Crown Natural Products, Nutrition Coalition, Capris Associate/BR Naturals, Pure Nootropics, TEK Naturals, CanaRx Services (2/26/19) and John Gray’s Mars Venus.

Triad Rx. This Alabama-based company was warned over a July 2017 inspection over problems in their sterile drug products practices. They were also cited for misleading or false statements in marketing materials and misbranded drug products

McKesson. The FDA issued a Warning Letter on Feb. 7 over a corporate headquarters and distribution facility inspection in June and July 2018. The agency cited significant violations of verification requirements in the supply chain for prescription drugs, failure to respond to illegitimate product notifications, failure to quarantine and investigate suspected products, and a failure to keep appropriate records of the suspect products.

United Pharmacy. Based in West Palm Beach, Fla., United Pharmacy was warned over issues with compounded drug products. Bella Pharmaceuticals received a similar warning on Feb. 11 as well.

Proandre SL. Based in Barcelona, Spain, Proandre was warned over an FDA inspection in June 2018, noting violations of CGMP regulations. The warnings revolve around quality control issues for its batch production operations.

Pure Source. Based in Doral, Fla., it received a Warning Letter from the FDA after a February and March 2018 inspection over CGMP violations. The primary citation is over failure to thoroughly investigate unexplained discrepancies or failures of a batch of its components, some of which were contaminated with bacteria.

Vivet Pharmaceuticals. The FDA warned this Chester Springs, Penn.-based company over a June 2018 inspection, largely over CGMP violations. It was cited for quality control issues as well as its drug listing.

ANDAPharm. Based in Fort Lauderdale, Fla., ANDAPharm received a Warning Letter on Feb. 28 for violations of CGMP regulations. They were primarily over failure to establish and follow adequate written procedures for cleaning and maintaining equipment, as well as problems related to failing to have a testing program to assess drug stability and other control systems.

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