Drugs

10 Observations in Aurobindo Unit FDA-483

FDA has released the form FDA-483 issued following an 11/10-11/18 inspection at the Aurobindo Pharma Unit IX active pharmaceutical ingredient (API) intermediate manufacturing facility in Telangana, India. The form’s 10 inspection observations were:

out-of-specification and complaint investigations for API intermediate products are deficient;
process validation is deficient to demonstrate that the firm’s manufacturing process can reproducibly manufacture an API intermediate to ensure that predetermined quality attributes are met;
analytical test methods and cleaning analytical methods are not validated and/or appropriately validated;
written procedures for the cleaning and maintenance of equipment validation are deficient;
established laboratory control mechanisms are not adequate;
the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed;
storage of key starting materials, raw materials, and intermediates is not adequate;
materials and intermediates are not always reevaluated, as appropriate, to determine their suitability for use after an established retest date;
schedules and procedures established for the preventive maintenance of equipment are not adequate;
computer systems used in the testing of a drug substance are not of appropriate design to facilitate operations for its intended use.

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