Following the 13 nonconformities that were revealed during a US Food and Drug Administration (FDA) inspection of a Mylan Pharmaceuticals manufacturing site, Focus obtained a copy of the company’s response to the agency via a Freedom of Information Act (FOIA) request. The response to the 31-page Form 483, which was issued after the FDA visit to the plant in Morgantown, WV earlier this year, outlines a total of 77 commitments to address the inspectional observations....

The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish. Introduction For pharmaceutical manufacturers, US Food and Drug Administration (FDA) inspections are an occasional part of being in business and perhaps a fact-of-life. While FDA is required to inspect drug manufacturing facilities every two years, the agency is also au...

The US Food and Drug Administration (FDA) on Tuesday released a heavily redacted Form 483 sent last month to Glenmark Pharmaceuticals' Solan, India-based manufacturing facility. One of the seven observations in the Form 483, first announced by the company on 28 November , noted that FDA inspectors found at least 13 quality documents "shredded in the teeth and surrounding internal moving parts of the shredder." FDA said the quality documents were not listed on the ...

The US Food and Drug Administration (FDA) on Wednesday released a Form 483 sent to Korea’s Celltrion with 12 observations, which an industry analyst believes could be the reason why the commercialization of Celltrion and Pfizer’s Inflectra (infliximab-dyyb), a biosimilar to Remicade, has not gone as well as planned in the US, though Pfizer says the limited uptake has more to do with Johnson and Johnson's exclusionary contracts. The Form 483 for the Incheon, Korea-base...

The US Food and Drug Administration (FDA) on Thursday said that lead test maker Magellan Diagnostics may have violated federal law in its handling of customer complaints and design validation for its LeadCare testing systems. FDA cited the issues in a 10-page inspection report stemming from a month-and-a-half long inspection of Magellan's North Billerica, MA facility from 10 May to 29 June 2017. A week into that inspection, FDA warned the public that all four of Magel...

The US Food and Drug Administration (FDA) in April warned Indian active pharmaceutical ingredient (API) maker Sal Pharma and handed an inspection report with six observations to major generic drugmaker Aurobindo Pharma. Warning Letter: Sal Pharma FDA's warning to Sal Pharma comes roughly 10 months after the agency inspected the company's Hyderabad, India facility in June and July 2016. Last February, the agency placed the firm on import alert . According to the warnin...

The US Food and Drug Administration (FDA) has issued an inspection report to major Indian generic drugmaker Lupin Limited following an inspection of its Goa, India facility earlier this month. The Form 483 details three observations made by FDA investigators during an inspection conducted 27 March–7 April 2017, and comes roughly a year after the company reported receiving nine observations from an earlier inspection of the facility. According to Lupin's website , the...

As China and India continue to manufacture about 80% of all active pharmaceutical ingredients (APIs) for the US market, the US Food and Drug Administration (FDA) is tasked with regulating these manufacturing sites and in 2016 that involved issuing hundreds of Form 483s and responding to more than 700 requests for the inspection reports. Thanks to the Freedom of Information Act, Focus obtained from FDA two lists detailing not only the 86 requests for the Form 483s issue...

Just a day before Rep. Tom Price (R-GA) was grilled by senators over his links to the medical device company Zimmer Biomet, the US Food and Drug Administration (FDA) released a Form 483 for the company’s Detroit-based site with 14 observations. The 58-page, heavily-redacted Form 483 follows the site inspection from 12 September 2016 to 22 November 2016. The first observation – on sterilization validation and a “test that has not been adequately validated” – and the seven...

The US Food and Drug Administration (FDA) on Tuesday released a Form 483 (which can be the precursor to a warning letter) with six observations to one of two Akorn Pharmaceuticals’ Decatur, Illinois-based sterile drug manufacturing facilities. The observations were uncovered during a 10-day inspection in June and include quality control issues, unrecorded or unjustified deviations from written production and process control procedures, quality control responsibilities an...

The US Food and Drug Administration (FDA) on Friday released a Form 483 issued 18 August to blood testing startup Theranos, citing the company for allowing patients to consent to sample collection in two Zika-related trials without approval of an institutional review board (IRB). The one-page FDA report says that the three-day inspection of Theranos' Palo Alto, CA facility in mid-August uncovered evidence that Theranos initiated clinical investigations for two clinical ...

The US Food and Drug Administration (FDA) on Tuesday released a Form 483 for Valeant’s Bausch & Lomb sterile drug manufacturing facility in Tampa, FL, citing the site for microbiological contamination of drugs purporting to be sterile. The eight-day inspection last February uncovered four observations detailing : Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up Procedures designed to prevent microbiological...