Drugs

API CGMP Deviations at Ali Pharmaceutical

A 9/26-10/3/22 FDA inspection at Ali Pharmaceutical Manufacturing in Omaha, NE, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A just-released 3/30 Warning Letter says specific deviations were:

failing to demonstrate that the firm’s manufacturing process can reproducibly manufacture an intermediate and API meeting its predetermined quality attributes;
failing to establish and follow written procedures for investigating critical deviations or the failure of intermediates and API lots to meet specifications; and
failing to ensure that API lots meet specifications before blending with other lots.

The letter also says Ali lacks an ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality, has an inadequate quality system, and did not properly address out-of-specification test results.

FDA reminds Ali that it considers contractors, such as contracted laboratories, as extensions of the manufacturer’s facility and says it is “essential that you understand your responsibility to operate in full compliance with CGMP and that you inform all your customers of any out-of-specification results or significant problems encountered during the testing of these drugs.”

The letter says the agency strongly recommends that Ali engage a qualified consultant to assist it in meeting CGMP requirements.

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

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