FDA Reveals How Manufacturing Facilities are Prioritized for Inspections | RAPS

“The Site Selection Model (SSM), used by CDER staff to prioritize manufacturing sites for routine quality-related inspections, considers risk related to drug (drug substance and finished product) quality as may arise from violations of the CGMP requirements in the Food Drug & Cosmetic Act (FD&C Act).

The SSM will use risk factors consistent with section 510 of the FD&C Act, which identifies specific risk factors and allows FDA to determine additional ones, including: “a) The compliance history of the establishment. b) The record, history, and nature of recalls linked to the establishment. c) The inherent risk of the drug manufactured, prepared, propagated, compounded, or processed at the establishment.””

Read the full source article: FDA Reveals How Manufacturing Facilities are Prioritized for Inspections | RAPS

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“Mutual Recognition” Kicks Into High Gear – FDA Law Blog

Stethoscope and books

“On October 31st, FDA made its long anticipated announcement recognizing the first European drug regulatory authorities capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight countries that were announced are: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom.”

Source: FDA Law Blog: “Mutual Recognition” Kicks Into High Gear

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The FDA conducted 39,774 inspections in 2013 | FDAzilla – FDA INSPECTION READINESS

FDA Investigator's Badge“The FDA ended 2013 with 39,774 inspections – a 5-year low.  It’s the first time the FDA has conducted less than 40,000 inspections since 2008 (when it conducted 39,522).”

Read the full article: via The FDA conducted 39,774 inspections in 2013 | FDAzilla – FDA INSPECTION READINESS.

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Pure Food and Drug Act passes in Congress, June 23, 1906 – Andrew Glass – POLITICO.com

English: Theodore Roosevelt.

English: Theodore Roosevelt. Public Domain – Wikipedia.

“On this day in 1906, the Pure Food and Drug Act cleared a hurdle toward its passage when the House and Senate both endorsed a joint conference committee report favoring the bill. The House vote was 240-17. President Theodore Roosevelt signed the landmark Progressive Era legislation into law on June 30.

The statute for the first time regulated food and drugs that moved in interstate commerce and forbade the manufacture, sale or transportation of poisonous patent medicines. It arose, with strong White House support, in the wake of exposés by such muckrakers as Upton Sinclair and Samuel Hopkins Adams.”

Read the full article: via Pure Food and Drug Act passes in Congress, June 23, 1906 – Andrew Glass – POLITICO.com.

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