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FDA Office of Product Quality | Annual Report 2017

A previous blog entry addressed the Office of Pharmaceutical Quality ‘One Quality Voice’ effort, an aspirational view of FDA’s efforts to ensure coordination in the review, inspection, and approval process as well as post-approval oversight of both facilities and products. Shortly after that publication, FDA’s Office of Product Quality published their first annual report that we address in this [...]

GMP Regulatory Newsletter: Summary Scan | Week of 3/25/18

Laws, Regulations, Guidance, and Concept Papers A slow week for guidance publication:  2 from FDA and 1 from WHO. The non-guidance area saw the usual collection from EMA, MHRA, FDA and 1 each from MHRA and TGA. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence Trial today. [...]

Week of Mar 18th 2018 | FDA Sent These Warning Letters to Device & Pharma Companies

FDA posted 7 warning letters this week. Among those we cover: 1 to an API firm 2 to finish pharmaceutical manufacturers 1 to a device manufacturer We cover these below. The warning letters issued to drug firms all have significant requirements associated with them that firms are to address. We include these requirements because they provide a roadmap of [...]

FDA Sent These 6 Warning Letters for Food Companies | March 2018

We took a snapshot of the 6 warning letters the FDA sent to food companies this month. Food violations ranged from failing to wear beard covers to failing to exclude pests from food plants. From companies in Seattle, New York, and more, here they are: A.C. Calderoni & Co., Brisbane, CA - 3 violations: Firm failed to have a [...]

By | 2018-03-29T16:36:35+00:00 March 29th, 2018|FDA Warning Letters, FDAzilla, Food|

The FDA’s “One Quality Voice”

FDA’s report on pharmaceutical quality for the 21st Century in 2004 put forth their vision for reorganization within the FDA that would strengthen their ability to ensure drug quality. As part of FDA’s reinvention and modernization, they created the Office of Product Quality ‘to promote “One Quality Voice” through the integration of review, inspection, surveillance, policy, and research for [...]

GMP Regulatory Newsletter: Summary Scan | Week of 3/18/18

Laws, Regulations, Guidance, and Concept Papers We have another slow week in the publication of guidance: FDA published 2 addressing post approval safety reporting for combination products and 1 regarding drug compounding EMA published 1 item addressing pharmacogenomic practices CDSCO (India) and TGA each published 1 We see the usual collection of non-guidance items from MHRA, EMA, FDA, and [...]

33 New FDA 483s | March 26th 2018

Last week, we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your job easier. Learn [...]

Week of Mar 11th 2018 | FDA Sent These Warning Letters to Device & Pharma Companies

FDA posted 11 warning letters this week: 3 were issued to duodenoscope manufacturers (we identified those last week) 2 warning letters went to device firms 1 to a contract testing laboratory in France 1 to a compounding pharmacy DRUGS/CONTRACT TEST LABORATORY: Quali-Controls & Quali-Controle C.E. BAC (Meru, France) received a warning letter on March 5th 2018 based on the [...]

46 New FDA 483s | March 22nd 2018

This past week, we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your job easier. [...]