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.

Actavis Laboratories Davie, FL (2/1): FDA inspected the firm 7/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish adequate written procedures for production and process control designed to assure that drug products manufactured have the identity, strength, quality, and purity they purport. Actavis also failed to establish control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Additionally, the company 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.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm632120.htm

AndaPharm Fort Lauderdale, FL (2/28): FDA inspected the firm 7/2018 and cited significant GMP violations for finished pharmaceuticals. For example, AndaPharm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment. The company also failed to establish and follow an adequate written testing program designed to assess the stability characteristics of its drug products.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm632415.htm

New Era Naturals Durango, CO (1/30): FDA inspected the firm 4/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications. New Era also failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Additionally, the company failed to establish and follow written procedures for the preparation of master production and control records designed to assure uniformity from batch to batch.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm632080.htm

Vilvet Pharmaceuticals Chester Springs, PA (2/25): FDA inspected the firm 6/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish an adequate quality control unit and procedures applicable to the 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. Vilvet also failed to establish adequate written responsibilities and procedures for reviewing batches made by its supplier. Additionally, the Warning Letter recommends that the company retain a third-party regulatory consultant to help with GMP compliance.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm632119.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