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FDAzilla

 •  December 17

We took a snapshot of the 3 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from failing to have correct expiration dates to failing to investigate the unexplained. From pharmaceuticals in China and India only, here they are (starting with the most recent):
Hangzhou Facecare Cosmetics Co....

FDAzilla

 •  November 21

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Acquisition of one pharmaceutical firm by another is preceded by due diligence efforts in many functional areas. Let’s talk about activities in the GMP area. Firms may not be able to fully rely on past inspections by the FDA to predict the extent of remediation...

FDAzilla

 •  November 21

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief On November 1, 2017, we published a blog that addressed a large collection of newly issued guidance for the generic drug industry. With this post, we continue with another three generic drug guidance that were issued recently. Consistent with the previous...

FDAzilla

 •  November 17

We took a snapshot of the 6 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from failing to prevent “mix-ups” to failing to adequately investigate. From pharmaceuticals in Wisconsin, India, and more, here they are (starting with the most recent):
Guangdong Zhanjiang Jimin Pharmaceutical...

FDAzilla

 •  November 9

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief The FDA has been on a bit of a tear in publishing guidance for devices and generic drugs. Here we address the CDRH guidance issued between September 29th and October 25th 2017 and provide summaries of their content. Seven guidance listed below are final, and one...

FDAzilla

 •  November 1

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief October has so far seen a flurry of guidance publications focused on generic drugs. It’s unusual to see so many guidance on one kind of product published almost simultaneously — though the device area seems to be making the same effort! Many of the generic drug...

FDAzilla

 •  October 18

We took a snapshot of the 5 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from sites failing to establish adequate quality control to failing to label products to bear adequate directions for use. From pharmaceuticals in China, New Mexico, and more, here they are (starting with the most...

FDAzilla

 •  October 13

Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month! Drug Recalls for September, 2017. Recalling Firm Class Product(s) Reason Andropharm LLC I 2 products, recall of all lots within expiry Marketed without an approved NDA/ANDA: product label states it contains anabolic...

FDAzilla

 •  September 25

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief One of the most thought-provoking presentations at the recent PDA / FDA meeting in Washington DC was given by Guy Villax, CEO of Hovione Pharmaceuticals. Hovione Pharmaceuticals offers a range of contract services including but not limited to, product...

FDAzilla

 •  September 25

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief While the drug GMPs haven’t changed much, if at all, in recent years, FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted. The FDA recently made available a description of their new operating model that will ensure...