Author Archives: Tony Chen

About Tony Chen

Tony Chen is Co-Founder of FDAzilla

Assessing Your Readiness State for FSMA: Stabilize, Then Benchmark

Assessing Your Readiness State for FSMA: Stabilize, Then Benchmark

I find that the FSMA readiness of major food brands and CPGs runs the gamut from “scrambling” to “got it covered” — and everywhere in between. Smaller companies have been given more time to prepare by the FDA. Larger companies have considerably less runway to get ready.

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FDA Sent These 10 Warning Letters for Pharma Companies | January 2017

We took a snapshot of the 10 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from products not meeting “the definition and standard for chocolate” to sites “refusing to permit the FDA inspection” altogether.

From pharmaceuticals in Italy, Pennsylvania, and more, here they are (starting with the most recent):
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FDA Sent These 5 Warning Letters for Pharma Companies | December 2016

We took a snapshot of the 5 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to put expiration dates on containers to failing to put soap in the bathrooms.

From pharmaceuticals in Canada, Spain, and more, here they are (starting with the most recent):
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FDA Sent These 7 Warning Letters for Pharma Companies | November 2016

We took a snapshot of the 7 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to maintain complete data to failing to prevent microbiological contamination.

From pharmaceuticals in Japan, New Jersey, and more, here they are (starting with the most recent):
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FDA Sent These 6 Warning Letters for Pharma Companies | October 2016

We took a snapshot of the 6 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from allowing unauthorized access to confidential data to forgetting to put expiration dates on drugs.

From 3 pharmaceuticals in the USA and 3 abroad, here they are (starting with the most recent):
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