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Dr. Reddy’s Laboratories Slapped With 483 After FDA Preapproval Inspection

Dr. Reddy’s Laboratories has been hit with another 483 for problems with its production facilities. FDA performed a preapproval inspection at the firm’s formulations manufacturing plant which is known as FTO 11. Dr. Reddy’s told the press that the agency gave them a two-item 483 that focused on subpar manufacturing standards. The FDA inspection took […]

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FDA Commissioner Wants To Revamp The Evidence Generation System

FDA Commissioner Rob Califf said last week that he wants to combat scientific misinformation and create new ways to increase the use of the evidence generation system that FDA relies on to make its drug approval decisions. Califf referred to the agency as a decision-making machine and an organization that is ‘a referee that plays […]

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FDA User Fee Bill Deadline Passes; FDA Reviewers May Be Laid Off

The fight over what should be included in the latest round of FDA user fee legislation – the money from the pharma industry that pays for drug and biologic reviews at the agency that must be reauthorized every five years – is reaching a climax this month. Congress is attempting to meet a recess deadline […]

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EMA Planning Transition To Reviewing Raw Clinical Data

FDA often talks about the fact that it’s the only global pharma regulator that reviews raw clinical data, meaning the data of individual patients during its pharmaceutical application reviews. This often allows FDA to avoid what could be misleading or biased data offered by a drug sponsor. This month, the European Medicines Agency (EMA) is […]

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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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