Drugs

Multiple Violations Seen in Skyless Inspection

A 5/2-5/16/22 FDA inspection at the Skyless LLC drug manufacturing facility in Ponce, Puerto Rico, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and other violations. A just-released 1/23 Warning Letter says specific CGMP violations were:

failing to have, 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, before release;
failing to conduct at least one test to verify the identity of each component of a drug product, and failing to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals; and
failure of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter says the firm’s responses to the CGMP inspection observations were inadequate. FDA also details unapproved new drug and misbranding violations for several of the firm’s drug products, along with establishment registration and listing violations.

“Based on the nature of the violations we identified at your firm,” FDA says, “we strongly recommend engaging a qualified consultant … to assist your firm in meeting CGMP requirements.”

Skyless was told to correct the violations promptly and to respond with a list of specific actions it has taken to address any 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

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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