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.

High Chemical Co., Waretown, NJ (7/2): FDA inspected the firm in February and found significant GMP deviations with active pharmaceutical ingredients (API). For example, the firm failed to ensure that, for each batch of API, appropriate laboratory tests are conducted to determine conformance to specifications. It also failed to design a documented, on-going stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates. FDA acknowledged that High Chemical committed to closing the company on or before 5/31. It asked the company to clarify if it intends to resume manufacturing or distributing any drugs or other API in the future and says the agency should be notified before any operations resume. To view the letter, click here.

Indoco Remedies Mumbai, India (7/9): FDA inspected the firm in January and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced. It also failed to ensure that laboratory records included complete data from all tests necessary to ensure compliance with established specifications and standards. To view the letter, click here.

Stratus BioSystems, Grapevine, TX (7/1): FDA inspected the firm in February and cited significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps). For example, Stratus failed to validate and approve a process according to established procedures where the results of processing cannot be fully verified by subsequent inspection and tests. The firm also distributed an HCT/P after the donor had a positive pre-processing culture on the amniotic membrane for Staphylococcus aureus. 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