Drugs

FDA Flags Manufacturing/Quality Lapses at Ipca’s India API Plant

FDA has cited Ipca Laboratories over multiple manufacturing and quality deficiencies following an inspection of the company’s active pharmaceutical ingredient (API) facility in India, according to a just-posted inspection report issued in December. FDA investigators inspected the facility in Palghar, Maharashtra, and documented three significant observations that raise concerns related to facility maintenance, analytical method validation, and controls to prevent cross-contamination during manufacturing campaigns.

In its first observation, FDA said buildings and facilities used to manufacture APIs were not adequately maintained to facilitate cleaning and minimize the risk of contamination. Inspectors reported peeling and missing paint on the ceiling of a clean room used for open processing of APIs destined for the U.S. market. Agency investigators also identified more than 20 cracks in the walls and ceiling of a weighing and packing room housing major production equipment.

FDA’s second observation focused on deficiencies in the verification of analytical test methods used to assess organic impurities. Investigators found that Ipca had not demonstrated that its high-performance liquid chromatography methods could generate reproducible and accurate results across an established column temperature range. FDA noted that quality control personnel acknowledged that slight changes in column temperature could affect retention times and potentially impact analytical results. Despite this risk, the firm failed to provide scientific data from controlled studies to support the suitability of the temperature range used during testing of U.S. batches, FDA said.

In a third observation, FDA cited inadequate controls to minimize the carryover of residual materials between successive batches of the same intermediate or API. The agency said Ipca’s cleaning validation procedures require more rigorous cleaning after a defined number of batches but do not establish a maximum campaign length in terms of days. FDA noted that the firm conducted extended manufacturing campaigns for certain APIs without providing scientific justification demonstrating that residual materials would not carry over between batches over that time period. FDA also said the company failed to produce data from controlled studies to support its cleaning practices for prolonged campaigns.

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