Drugs

CGMP Violations at Outin Futures

A 3/25-3/29 FDA inspection at Outin Futures Corp.’s drug manufacturing facility in Chungcheongbuk, Republic of Korea, identified significant current good manufacturing practice (CGMP) regulation violations for finished drugs. A just-released 9/25 Warning Letter also says the firm’s Neogen Dermalogy Airy sunscreen product is misbranded and its introduction or delivery into interstate commerce is prohibited. Specific CGMP violations listed in the letter were:

failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
failure to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records;
failure to establish a 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, including drug products manufactured, processed, packed, or held under contract by another company, and failure to establish adequate written responsibilities and procedures applicable to the quality control unit; and
failure to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess.

The letter says the firm’s sunscreen product is misbranded because its labeling fails to contain the information required by the over-the-counter monograph for such products. It also is misbranded, FDA says, because the label fails to contain adequate warnings, and fails to include a domestic address and telephone number through which the responsible person may receive a report of a serious adverse event associated with the product.

FDA recommends that Outin engage a qualified consultant to assist it in meeting CGMP requirements. It says the firm’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.

Outin was told to correct the violations promptly and to respond with a list of specific actions it has taken to address violations and prevent their recurrence, with a schedule for completing the corrections.

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