Drugs

CGMP Issues at India’s Shimoga Chemicals

A 1/19-1/23 FDA inspection at the Shimoga Chemicals drug manufacturing facility in Sengli, Maharashtra, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 7/13 Warning Letter says the specific violations were:

failure to ensure that all specifications, sampling plans, and test procedures are scientifically sound and appropriate to ensure that the APIs conform to established standards of quality and purity;
failure to demonstrate that the manufacturing process can reproducibly manufacture an API meeting the predetermined quality attributes; and
failure of the firm’s quality unit to exercise its responsibility to ensure the manufactured APIs comply with CGMP.

FDA 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. The agency acknowledges the firm’s commitment to retain a qualified third-party consultant to audit its operation and assist it in meeting FDA requirements. It also acknowledges Shimoga’s 5/14 recall of clomiphene citrate USP due to deficiencies with the quality system and data integrity concerns. FDA placed all of Shimoga’s drugs and drug products offered for import into the U.S. on a 6/2 Import Alert.

The company was told to correct the deviations promptly and to respond with a list of specific actions it has taken to address the deviations 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’

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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