FDA Draft Guidance Summarized: Delaying, Denying, Limiting, or Refusing a Drug Inspection

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Updated November 4, 2020

Some the links broke in the original post below.

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FDA Issues Draft Guidance on Definition of Denying, Delaying, Limiting or Refusing to Permit Inspection - The National Law Review

Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection - FDA.gov (PDF)

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Facility Inspection Guidance Issued by FDA: Delaying, Denying, Limiting, or Refusing a Drug Inspection - FDA Lawyers Blog:

" . . . in particular Section 707 of FDASIA, which added 501(j) to the FD&C Act, the FDA now deems as adulterated a drug that "has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection". (emphasis added)"

Read the draft guidance:
FDA - Draft Guidance for Industry - Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (PDF)

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New FDA Guidance - Cosmetic GMPs

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Updated July 22, 2021

The link in the original post broke.

Read more about the topic here:

Cosmetics Guidance Documents - FDA.gov

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Guidance Documents > Guidance for Industry: Cosmetic Good Manufacturing Practices:

" . . . as part of an international harmonization effort with the International Cooperation on Cosmetic Regulations (ICCR), FDA (or we) agreed to consider the current International Organization for Standardization (ISO) standard for cosmetic GMPs (ISO 22716:2007) when revising this guidance. We reviewed ISO 22716 and decided to incorporate, modify, or exclude specific aspects of it into this guidance based on our experience."

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FDA - Foods & Veterinary Medicine Program Reorganized

SCVNews.com | FDA Reorganizes Foods & Veterinary Medicine Program | 01-28-2013:

"Under the reorganization, the Office of Foods is now the Office of Foods and Veterinary Medicine, led by Michael Taylor, the Deputy Commissioner for Foods and Veterinary Medicine.

The Office of Foods was created in 2009 to elevate leadership on food and feed safety and to reflect the vision that success on food and feed safety requires an integrated approach that leverages resources. This reorganization will further the integration that has already been achieved and better position the program to implement the FVM Strategic Plan for 2012-2016 and the Food Safety Modernization Act, which emphasizes a systematic approach to risk-based priority setting and resource allocation."

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FDA Exerts FSMA Authority - Food Safety

Updated June 24, 2024

The original link broke.

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New Era of Smarter Food Safety - FDA.gov

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FDA Writing New Chapters in Food Safety History | FDA Voice:

"With the suspension of Sunland’s food facility registration, for the first time FDA was, in effect, able to independently prevent a company from distributing food that could have caused harm to consumers. This was our first use of this new authority granted by the FDA Food Safety Modernization Act (FSMA), and it will be an important tool for FDA to use in the future to ensure the accountability of companies for the safety of the food they produce.

Under the decree, Sunland must hire an independent sanitation expert to develop a program to ensure products are produced in a sanitary way and according to good manufacturing practices. The company must also conduct environmental testing to ensure that disease-causing bacteria aren’t present in its facility or in its final food products. FDA will evaluate the programs Sunland sets up, and will not allow the company to operate its peanut butter plant until we determine that its products can be safely produced. "

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FDA Increases Winery Inspections

FDA Takes a Growing Interest in Winery Safety | News | News & Features | Wine Spectator:

"While winery inspections are not new, they’re being ramped up under the 2011 Food Safety Modernization Act, according to FDA spokeswoman Patricia El-Hinnawy.

The federal law mandates that the FDA inspect all food processing establishments. The frequency of inspections is based on safety risk and compliance history. While wineries are considered low risk because the fermentation process kills pathogens, all food facilities must be inspected within seven years and at least once every five years after that. “The FDA may be conducting more inspections [at wineries] than it has done in the recent past, in order to meet the [law’s] requirements,” El-Hinnawy said."

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FDA ramps up role as safety sheriff

Updated Oct 10, 2017

The original link broke.

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ONLY IN THE WORLD-HERALD; FDA RAMPS UP ROLE AS SAFETY SHERIFF FOOD MANUFACTURERS AND FARMERS PREPARE

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FDA ramps up role as safety sheriff - Omaha.com:

"The federal Food Safety Modernization Act will result in numerous changes — some large, some small — for food manufacturers and farmers in 2012 and beyond as the Food and Drug Administration continues its slow, steady rollout of new regulations. During the new law's first year, little has changed other than sweeping educational efforts to prepare farmers and food manufacturers for ramped-up federal inspection efforts. The inspections will include more, and increasingly intense, reviews of food safety and health protocols. But for 2012 and beyond, companies are preparing for financial effects. Over the next five years, the FDA is planning to issue more than 50 new rules, add inspectors and ramp up oversight efforts to the tune of $1.4 billion."

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Drug Safety and Accountability Act of 2010

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Sen. Michael Bennet (D-CO) introduced a bill earlier this month, the Drug Safety and Accountability Act of 2010, which is designed to improve regulatory oversight of drug-manufacturing facilities and improve related quality standards and monitoring.

Bennet's press release, Senate Introduces New Bill on Drug-Manufacturing Quality Standards, says:

The bill would strengthen manufacturer quality standards, enhance the FDA’s ability to protect Americans through improved tracking of foreign manufacturing sites, and give the FDA much-needed authority to recall potentially dangerous drugs.

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Avoid The DOJ - FCPA Violations - Foreign Corrupt Practices Act

I never heard about the FCPA (Foreign Corrupt Practices Act) until reading about it today. Wikipedia says FCPA addresses accounting transparency requirements under the Securities Exchange Act of 1934 and another concerning bribery of foreign officials.

Anyways, FDANews reports that the Department of Justice’s (DOJ) FCPA and healthcare fraud units are beginning to work together to investigate FCPA violations in the device and pharmaceutical industries. The DOJ has more information about FCPA on their website.

Here's why you need to care. The DOJ wants to aggressively enforce and investigate violations of the FCPA, targeting pharmaceutical and medical device companies as well as their individual executives and board members; this leaves them open to potentially massive legal and financial liabilities.

Additional Resources:
Bribery Abroad: Lessons from the Foreign Corrupt Practices Act

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FDA Launches New Tobacco Products Center

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The Food & Drug Administration (FDA) has launched its new FDA Center for Tobacco Products. The Center will oversee the implementation of the Family Smoking Prevention & Tobacco Control Act signed by President Obama in June 2009. The FDA's responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products and establishing and enforcing advertising and promotion restrictions.

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The Medical Device Safety Act of 2009

It's a firestorm! The FDA announced that makers of certain older and risky medical devices will have to prove that their products are safe and effective according to the New York Times. This is a very hot issue. Related to this, I just read an editorial published by NEJM (the New England Journal of Medicine): The Medical Device Safety Act of 2009. Who's side are you on? The patient? Industry? Litigation attorneys? Others? 

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FDA Draft Guidance - Drug Supply Chain and SNIs

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Updated October 24, 2022:

I'm glad to see these new proposed standards. With the presence of drug counterfeiting, diversion, and quality issues, I'm hopeful these standards can bring greater safety and confidence to the supply chain. This FDA Guidance for Industry Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages - Draft Guidance is the first of several guidances and regulations that the FDA may issue to implement Section 913 of the Food and Drug Administration Amendments Act of 2007. This guidance recommends the standards that industry should use for the identification of individual packages containing prescription drugs. These standards will facilitate the adoption of a uniform electronic track and trace system for prescription drugs to further improve their safety and security. The details of the draft guidance follow . . . TABLE OF CONTENTS I. INTRODUCTION II. BACKGROUND A. Food and Drug Administration Amendments Act of 2007 B. Scope of this Guidance III. STANDARDIZED NUMERICAL IDENTIFIERS A. What should be designated as a package-level SNI? B. Does the SNI include expiration date and/or lot or batch number? C. Why did FDA select the serialized NDC for package-level SNI? Do you agree with the direction this FDA draft guidance is taking us? 

Related Posts: FDA Draft Guidance On Good Importer Practices FDA - Global Drug Supply Chain Needs Better Oversight CA E-Pedigree - Pedigree and Serialization 

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About The FDA Orange Book - Slide Deck (free)

Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

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FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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If you use the FDA's Orange Book, or have an interest in generic drugs, exclusivity, and patents, then take a gander at this slide deck from an FDA CDER staff member, "The Orange Book (slide deck; free)." The slide deck covers . . .

• What is the Orange Book?
• What is exclusivity and how does it work?
• How is the Food and Drug Administration (FDA) involved with patent protection?

Related Posts:
FDA Orange Book - Online

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FDA Enforced Laws And Related Statutes

Updated June 28, 2025

The original links broke.

You can still read about the same topic here:

Laws Enforced by FDA - FDA.gov

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Since this blog covers "GMPs (FDA Good Manufacturing Practices) and other regulations," I guess it's only fair to devote a post to the FDA's "Laws Enforced by the FDA and Related Statutes." They post a pretty exhaustive list of laws and statutes, which they categorize in the following way . . .

Federal Food, Drug, and Cosmetic Act (FD&C Act) United States Code (U.S.C.) Title 21, Chapter 9 Cross-reference of FD&C Act and U.S. Code section numbers Amendments to the FD&C Act Other Laws

It should be noted that some of the laws may have been amended since their original date.

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