Texas Pharmaceutical Company Hit With 483 For Missing Records and Inadequate Processes
A Texas drug manufacturer received a 483 on June 10, 2022 for missing records, inadequate processes and inappropriate controls as well as other CGMP violations. The company is Monarch PCM and it’s based in Fort Worth. The facility manufactures tablets, liquids, lotions and creams, and was audited by FDA between June and August 2021. The […]
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Congress Urges FDA To Adopt Clearer, Neutral Rules For Pharmaceutical Drug Ads
Several members of the US House, including Katie Porter, who often interrogates pharmaceutical executives on The Hill, wants to force FDA to adopt a proposal from 2010 about some of the distractions that are in direct-to-consumer drug advertisements. The long-delayed proposal would come up with standards that would ensure that pharmaceutical drug risks and important […]
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FDA Notes cGMP Failures In Warning Letter For 503B Compound Outsourcing Facility
After it stopped sending FDA warning letters to 503B outsourcing facilities in 2021, FDA gave a warning letter in June 2022 to Hybrid Pharma after an FDA inspection that concluded in late 2021. It looks like FDA is returning aggressively to the 483 and warning letter trend, as the same pharmaceutical company got another warning […]
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Aurobindo Pharma Hit With Warning Letter From Indian SEC After More FDA Questions
Generic drug manufacturer Aurobindo Pharma based in India has been under the gun from FDA for years, but now the company is getting unwanted attention from Indian regulators. The website Business Standard in India reported last month that the company was sent a warning letter from the Security Exchange Board of India (SEBI). The warning […]
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FDA Hits US API Facility With Warning Letter When Workers Destroy Cleaning Logs
A drug manufacturing facility that is owned by the Netherlands-based API company Fagron Group is being criticized by FDA after a worker was found destroying a cleaning log. One of the company’s plants in Minnesota got an FDA warning letter in June after a cGMP inspection in 2021 that showed several cross-contamination problems. FDA stated […]
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FDA Gives 483 To Spanish Drug Ingredient Maker Bioberica
FDA cited Spanish drug ingredient maker Bioberica with an FDA 483 in May. The drug facility, which is located in Spain, was inspected by FDA inspectors in January and February 2022. During the audit, FDA found several cGMP issues involving improper cleaning procedures and microbiological contamination. The company was cited with five 483 observations, including […]
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FDA Approves New Cancer Drugs Faster Than EMA
The FDA is faster to approve new cancer drugs compared to the EMA or European Medicines Agency, according to a study released in JAMA Network Open last week. Investigators at Imperial College London did a clinical study involving 90 cancer drugs that were approved by the FDA and EMA between 2010 and 2019. They looked […]
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FDA Oversight Of Drug Manufacturing Facilities Plunged During Pandemic
Every year, FDA keeps track of how effectively it inspects drug manufacturing facilities and how often it issues FDA inspection follow-up letters to facilities that have major cGMP problems. But last year, there was a major drop in FDA productivity for inspections and follow-ups. A recent FDA analysis found that FDA sent out only 70% […]
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How The US And FDA Can Reduce Medical Device Shortages
During the pandemic in 2020, FDA got new authority from Congress under the CARES Act to prevent shortages of medical devices. The CARES Act has language requiring medical device companies to give FDA information on device availability and when there may be possible disruptions of device availability during an emergency. Because of this new agency […]
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Italian Antitrust Regulators Fine Pharma Company For ‘Excessive Pricing’ of Disease Drug
Antitrust officials in Italy fined a drugmaker almost $4 million last month for years of what they termed ‘excessive price hikes’ for a rare disease drug. This is the latest occurrence in Europe where regulators are dropping the hammer on pharmaceutical companies for allegedly overcharging customers. The medicine involved is called CDCA and is used […]
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