FDA Policy/General

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.

BBC Group, Pumei Town, China (8/4): FDA inspected the firm 3/22-26 and cited significant GMP violations for finished drugs. The agency said BBC failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records or other records. It also cited the company for failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. The agency recommended that the company retain a qualified consultant to perform a comprehensive audit of its entire operation for CGMP compliance and then assist it in meeting CGMP requirements. To view the letter, click here.

Lepu Medical Technology, Beijing, China (7/29): FDA says the company is selling three Covid-19 test kits without marketing approval, clearance, or authorization from FDA. It says the kits are adulterated because the firm does not have approved PMAs in effect for them. The kits also are misbranded because Lepu did not notify FDA of its intent to introduce the devices into commercial distribution. Lepu was told to take prompt action to address the violations cited in the letter and to respond with a list of specific steps it has taken to address the violations, with copies of related documentation. To view the letter, click here.

Sanit Technologies (Durisan), Sarasota, FL (7/27): FDA 3/1-5 inspected the drug manufacturing facility and found GMP violations for finished drugs. Specifically the agency cited the firm’s quality control unit because it failed to exercise its responsibility to ensure drug products manufactured comply with GMPs and meet established specifications for identity, strength quality, and purity. The letter also cites concern about Burkholderia cepacia complex in non-sterile, water-based drug products. FDA acknowledges the company's decision to cease all production and distribution of drug products from the site as of 6/30. The letter says remediating the CGMP violations will be necessary if Sanit, a successor, or an acquirer resumes drug manufacturing operations at the site for the U.S. market. To view the letter, click here.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome