Indian API Plant Receives FDA 483
The Indian API company Lupin has been criticized by FDA before. After it was cited for inadequate manufacturing operations and other cGMP violations last summer, the genetics drug company still has not cleaned up its operations. Now Lupin’s API plant in Tarapour, India has been hit by an FDA 483 after an FDA inspection from […]
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Questions Remain After FDA Offers New Designation To Medical Device Manufacturers
In 2017, FDA launched a new regulatory program to speed up the development of medical devices. It’s estimated the program has helped a minimum of 45 medical devices come to market. It is believed more than 650 medical devices have what is known as ‘breakthrough designation’, which means FDA thinks the device could be more […]
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FDA Appears To Be Tightening Regulations For Drug Approvals
In a recent endometriosis application for Myfembree by Myovant and Pfizer, FDA included language that is being seen more often, according to pharmaceutical experts. In the FDA notice, the agency noted deficiencies that prevent discussion of labeling or post-marketing requirements and commitments. This might look like gobbledygook, but some industry analysts are starting to see […]
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2 US Drug Manufacturers Get FDA Warning Letter For Poor Investigations, Lax Testing and Validation
Two US drug manufacturers were hit with an FDA warning letter recently for cGMP violations connected to inadequate investigations, sloppy testing of incoming ingredients, as well as improper ethanol screening. Other FDA issues were related to improper validation of drug manufacturing processes, and both companies were hit with repeat violations. The FDA warning letters were […]
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FDA Issues Device Cybersecurity Draft Guidance
FDA issued a new draft guidance last week that affects medical device cybersecurity. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions was written to stress how important it is to protect medical devices during the product’s entire life cycle. The new guidance is intended to replace the previous guidance on the […]
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FDA Issues Warning Letter To Stem Cell Company For cGMP Violations
FDA issued a warning letter last month to Smart Surgical DBA Burst Biologics for marketing and sending allogeneic stem cell items that are unapproved. The company also had major violations from cGMPs and good tissue practices (CGTP). The FDA warning letter was posted to the agency’s site in February 2022. It follows an FDA inspection […]
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Cadila Healthcare Hit With 483 After Rare International FDA Inspection
After a 10-day FDA inspection in late Feb and early March 2022, FDA sent a 483 with several serious observations to Cadila Healthcare and its sterile injectable manufacturing facility in Jarod, India. FDA noted in the inspection documents that the facility mostly makes injectable drugs for the American market. But FDA noted that not only […]
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What’s Going On With FDA and Computer Software Assurance (CSA)?
Computer software assurance – CSA – is the new FDA guideline for validating computer systems – CSV. Many in the pharmaceutical and regulatory industries hail CSA as a game changer. The idea of less expensive computer and software validation sounds wonderful, but many drug firms are unsure how to interpret the new guidelines and put […]
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GAO Recommends Overhauling FDA Foreign Inspection Program
Last month, the Government Accountability Office or GAO raised concerns about the FDA foreign inspection program for pharmaceuticals, saying the program should be revamped. The GAO report comes amind FDA’s challenges in doing foreign cgmp inspections during the COVID era. In 2020 when the pandemic began, FDA stopped most foreign inspections temporarily. Although it planned […]
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FDA Resumes Foreign Inspections Amid Quality Concerns
FDA resumed domestic drug and device inspections in February 2022 that sometimes result in a 483 or FDA warning letter, and is about to resume foreign inspections, as well. As the agency confronts a two-year cgmp inspection backlog after its COVID-19 pause, lawyers say FDA should use this as an opportunity to deal with frequent […]
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