When was your last FDA inspection? You may believe that the likelihood of an FDA inspection happening to your company is low. However, medical device companies registered with FDA with class II and ...

It’s critical to keep your workplace equipment clean and calibrated—especially in the realm of pharmaceutical manufacturing. Now, Dr. Reddy’s failure to uphold those standards has landed the Indian ...

In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency ...

Should you ever have an FDA inspection, you’re going to want to know what to do after. And if you’re a medical device company with class II or class III products registered with FDA, you need to be ...

FDA inspections ensure compliance with GMPs, focusing on documentation practices, SOPs, and non-conformances. Inspections can be surveillance, for-cause, application-based, or follow-up, and occur ...

SANTA CLARITA, Calif.--(BUSINESS WIRE)--TriMed, Inc., an orthopedic medical device developer and manufacturer for the treatment of the extremities through Open Reduction Internal Fixation (ORIF), ...

This is regarding an inspection of your pharmaceutical manufacturing facility, Batamandi (Unit II), in Paonta Sahib, India by Investigator Jose R. Hernandez and Chemist Susanna E. Ford, during the ...

The number one reason for Form 483 observations is “Procedures not in writing or not fully followed.” This infraction was noted in 160 separate Form 483 instances (1). In these instances, the 483s ...

The Food and Drug Administration (FDA) has released an Excel file that lists all general inspection citations included on every FDA Form 483 (Inspectional Observations) issued for almost the past ten ...

The FDA issued a warning letter last year to PharMEDium Healthcare Holdings, the large compounding pharmacy operation that AmerisourceBergen ($ABC) said last week it ...

The Food and Drug Administration recently made public two warning letters issued in November 2018 involving significant violations of federal law. Violators have 15 working days to respond in writing.