FDA Policy/General

Recent FDA Warning Letters

Below are the FDA Warning Letters published during our annual end-of-year holiday break.

Cao Medical Equipment Co. Hebei, China (11/30/2018): FDA inspected the firm 7/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to perform, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for its drug products. The firm also failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm628119.htm

Genetech San Diego, CA (11/29/2018): FDA inspected the firm 6/2018 and cited human cell, tissue, or cellular or tissue based product violations related to its human umbilical cord blood-derived cellular products ReGen5, ReGen10, and ReGen30 for allogeneic use. For example, the firm failed to have a responsible person determine and document the eligibility of a cell or tissue donor based upon the results of donor screening and donor testing. The firm also failed to screen a donor of cells or tissues by reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm628019.htm

Hybrid Pharma, Deerfield Beach, FL (11/30/2018): FDA inspected the outsourcing facility 7/2016 and cited drug compounding violations. For example, the facility compounded drug products using sildenafil, human chorionic gonadotropin, and testosterone cypionate, which do not appear on FDA’s approved bulk drugs list. Additionally, some of the facility’s drug products did not include required information on the labels, such as “This is a compounded drug,” and “Not for resale.”
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm627759.htm

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