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Search posts on Warning Letters and 483s

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Enforcement Spotlight: Retests Prove Key Data Integrity Concern in Recent Warning Letter

On April 24, FDA issued a warning letter to contract testing laboratory International Trading Pharm Lab Inc., located in Paterson, N.J. Consumer Safety Officer Niketa Patel conducted the initial inspection October 15-29, 2019. This inspection resulted in a 483 and an Official Action Indicated classification due to data integrity issues.

RECENT POSTS

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CMC Challenges and Opportunities in Latin America

The Latin American region of the globe—which includes large countries such as Brazil, Mexico, Argentina, Columbia, and Peru—is undergoing a transformation marked by the stepwise harmonization of pharmaceutical regulations with international norms and standards. While it is a slow process and each country’s regulatory agency faces its own unique journey, progress is being made.

Read More »
Papers on a Table

The FDA Inspection is Over: What Happens Next?

In this conclusion to the four-part series summarizing Steven Niedelman’s May 28 Govzilla webinar presentation on FDA inspections, Niedelman outlines the steps following the conclusion of an FDA inspection. Part I provided background on FDA inspection authority while Part II looked at the different types of inspections FDA conducts. Part III offered advice on interacting with FDA investigators once they are onsite.

Read More »
Capsules

FDA Warning Letters Week of 8/30/2020: Cleaning Validation Issues & Adulterated Products at CMO

Last week, FDA posted two Warning Letters to drug firms. One has already received considerable attention. This one was issued to one of Mylan’s sites in India and is similar to one the company received for another Indian site last year. Additionally, the Warning Letter addresses similar concerns as one issued to a U.S. Mylan site in 2018. That Warning Letter cited issues with solvent recovery and cleaning validation.

Read More »

RECENT POSTS

Globe Showing Latin America

CMC Challenges and Opportunities in Latin America

The Latin American region of the globe—which includes large countries such as Brazil, Mexico, Argentina, Columbia, and Peru—is undergoing a transformation marked by the stepwise harmonization of pharmaceutical regulations with international norms and standards. While it is a slow process and each country’s regulatory agency faces its own unique journey, progress is being made.

Read More »
Papers on a Table

The FDA Inspection is Over: What Happens Next?

In this conclusion to the four-part series summarizing Steven Niedelman’s May 28 Govzilla webinar presentation on FDA inspections, Niedelman outlines the steps following the conclusion of an FDA inspection. Part I provided background on FDA inspection authority while Part II looked at the different types of inspections FDA conducts. Part III offered advice on interacting with FDA investigators once they are onsite.

Read More »
Capsules

FDA Warning Letters Week of 8/30/2020: Cleaning Validation Issues & Adulterated Products at CMO

Last week, FDA posted two Warning Letters to drug firms. One has already received considerable attention. This one was issued to one of Mylan’s sites in India and is similar to one the company received for another Indian site last year. Additionally, the Warning Letter addresses similar concerns as one issued to a U.S. Mylan site in 2018. That Warning Letter cited issues with solvent recovery and cleaning validation.

Read More »