FDA Policy/General

Latest FDA Warning Letters

Advanced Botanical Consulting and Testing, Tustin, CA (6/4): FDA inspected the contract testing laboratory 11/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods. FDA said it did not use United States Pharmacopeia monograph methods to test multiple USP monograph drug products, and it did not show method equivalency or superiority for its methods. Additionally, Advanced Botanical failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards. And, FDA said the company’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. To view the letter, click here.

Spectrum Laboratory Products, Gardena, CA (6/4): FDA inspected the firm 11/2018 and cited significant GMP deviations for active pharmaceutical ingredients (API). For example, Spectrum failed to transfer all quality or regulatory information to its customers. Additionally, its quality unit failed to ensure that critical deviations are investigated and resolved. To view the letter, click here.

Vida International, Taipei, Taiwan (5/29): FDA inspected the firm 12/2018 and cited significant GMP violations for finished pharmaceuticals. For example, Vida failed to perform, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient. The company also failed to conduct at least one test to verify the identity of each component of a drug product. Additionally, it failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products. 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