Drugs

12 Observations in Celltrion FDA-483

FDA has released the FDA-483 issued following a 5/22-26/17 and 5/29-6/2/17 inspection at the Celltrion drug manufacturing facility in Incheon, Korea. The 12 inspection observations were:

· failing to thoroughly review any unexplained discrepancy, whether or not the batch has already been distributed;
failing to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
· failing to have procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation of the sterilization process;
· aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions;
equipment used in the manufacturing areas of a drug product is not of appropriate design;
failing to determine that the firm’s manufacturing process can reproducibly manufacture drug substance meeting its predetermined quality attributes;
laboratory records do not include complete data derived from all tests, examinations, and assay necessary to assure compliance with established specifications and standards;
failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel;
failing to follow procedures for preparation of master production and control records;
failing to document data contemporaneously; and
batch production records do not contain complete information relating to the production and control of each batch.

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

Read more

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