FiercePharma

FDA hits Spanish drug substance maker Bioiberica with a Form 483

The FDA is citing Spanish drug materials maker Bioiberica for a number of manufacturing issues, which are outlined in a Form 483. The facility, which is located in Palafalls, Spain, was inspected by ...
FiercePharma

After issuing Form 483, FDA classifies Aurobindo plant as only needing 'voluntary' action

The FDA has issued its final inspection report for an Aurobindo plant in India after a September inspection and a subsequent Form 483. The agency classified the plant as needing "voluntary" action, ...
JD Supra

A Wrinkle in the Supply Chain: FDA’s First DSCSA 483 for a Dispenser

The US Food and Drug Administration (FDA) issued an inspectional observation (Form FDA 483) to a Texas med spa, Pure Indulgence Aesthetics, citing Drug Supply Chain Security Act (DSCSA) violations for ...
MD&M East

That Time FDA was ‘Unusually Thorough’ on a Form 483

Having noticed an uptick in medical device recalls and FDA warning letters to medtech companies this year, it seems an appropriate time to look back on a Form 483 from December 2016 that surprised ...
Becker's ASC

FDA Form 483 Outlines Conditions Observed at NECC

The FDA has released a copy of its Form 483, which outlines observed conditions at the New England Compounding Center in Framingham, Mass. The NECC is under investigation for contaminated products ...
JD Supra

Dismissal of Securities Claims Against Utah Biotech Company Provides Guidance in Securities Cases Involving Food & Drug Administration Form 483 Inspections

PolarityTE, Inc. (“PolarityTE”) is a biotechnology company headquartered in Salt Lake City, Utah that develops regenerative tissue products. 2 PolarityTE’s flagship product is a tissue product called ...
MD&M East

Responding to FDA Form 483 and Warning Letters: Dos and Don’ts

There is a scene in the old Rodney Dangerfield movie Back to School in which Dangerfield’s character, Thornton Melon, is preparing to take an oral exam from all his professors. One particularly stern ...