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Types of FDA Inspections

The FDA conducts several types of inspections to help provide access to needed medical products and to protect consumers and patients from unsafe products:

FDA orangebook
14 Sep 2024

FDA Roundup: September 13, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA orangebook
14 Sep 2024

September 13, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA orangebook
14 Sep 2024

SSM Health Care St Louis dba SSM St Clare Health Center. Fenton, MO. 483 issued 02/08/2024

Task Description Request Please post to the Compounding Inspections Web Page Record Date 02/08/2024 Short Title (70 char) SSM Health Care St Louis. Fenton, MO. 483 issued 02/08/2024 FEI Number 1972829

FDA orangebook
13 Sep 2024

UPDATED AGENDA INFORMATION: September 13, 2024: Meeting of the Gastrointestinal Drugs Advisory Committee Meeting Announcement - 09/13/2024

September 13, 2024: Meeting of the Gastrointestinal Drugs Advisory Committee Meeting Announcement

FDA orangebook
13 Sep 2024

FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection

On September 12, 2024, the Food and Drug Administration approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) for subcutaneous injection for all the adult indications as th

FDA orangebook
13 Sep 2024
FDA orangebook
13 Sep 2024

Drug Trials Snapshots: LAMZEDE

LAMZEDE is an enzyme replacement therapy that is used for the treatment of adult and pediatric patients with alpha-mannosidosis.

FDA orangebook
13 Sep 2024

FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause

FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause. Stop medicine if signs and symptoms of liver injury occur.

FDA orangebook
13 Sep 2024

FDA Adds Warning About Rare Occurrence of Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes Due to Menopause. Stop Medicine if Signs and Symptoms of Liver Injury Occur - Drug Safety Communication

The FDA is warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and symptoms suggesting liver injury,

FDA orangebook
13 Sep 2024

FDA Authorizes First Over-the-Counter Hearing Aid Software

The FDA authorized the first over-the-counter hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones.

FDA orangebook
12 Sep 2024

Join FDA for the First National Hispanic/Latino Family Cancer Awareness Week, Sept. 20-26

Project Community within the U.S. Food and Drug Administration’s Oncology Center of Excellence (OCE) will hold the first National Hispanic/Latino Family Cancer Awareness Week Sept. 20-26, 2024, to inc

FDA orangebook
12 Sep 2024

September 12, 2024

The FDA authorized the first over-the-counter hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones.

FDA orangebook
12 Sep 2024

FDA-CDER and HESI | Nitrosamine Ames Data Review and Method Development Workshop - 10/15/2024

The Food and Drug Administration Center for Drug Evaluation and Research and Health & Environmental Sciences Institute Global agree to co-sponsor the Nitrosamine Ames Data Review and Method Develo

FDA orangebook
12 Sep 2024

Drug Trials Snapshots: IMDELLTRA

IMDELLTRA is a drug approved for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC), whose cancer has progressed after prior treatment with chemotherapy that contains platinum.

FDA orangebook
12 Sep 2024

FDA Issues Warning Letters to Two Chinese Firms Regarding Data Quality and Integrity Concerns, Violative Lab Practices

FDA issued warning letters to two Chinese nonclinical testing laboratories, citing both for laboratory oversight failures and animal care violations that raise concerns about the quality and integrity of data generated by the labs.

FDA orangebook
12 Sep 2024

September 11, 2024

FDA issued warning letters to two Chinese nonclinical testing laboratories, citing both for laboratory oversight failures and animal care violations that raise concerns about the quality and integrity of data generated by the labs.

FDA orangebook
12 Sep 2024

FDA Rare Disease Innovation Hub

FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.

FDA orangebook
11 Sep 2024

FDA Roundup: September 10, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA orangebook
11 Sep 2024

Drug Trials Snapshots: ELFABRIO

ELFABRIO is an enzyme replacement therapy that is used for the treatment of Fabry disease in adult patients.

FDA orangebook
11 Sep 2024

Streamlining Drug Development and Improving Patient Care: CDER Quantitative Medicine Center of Excellence

Streamlining Drug Development and Improving Patient Care: CDER Quantitative Medicine Center of Excellence

FDA orangebook
11 Sep 2024

BsUFA III: Fiscal Years 2023-2027

New legislation will be required for FDA to continue collecting biosimilar user fees in future fiscal years. Information related to FDA’s preparation for the third reauthorization of BsUFA will be hosted here on this page as it becomes available.

FDA orangebook
11 Sep 2024

Orean Personal Care Ltd. - 682813 - 08/29/2024

CGMP/Finished Pharmaceuticals/Adulterated

FDA orangebook
11 Sep 2024

Avaria Health & Beauty Corp. - 685248 - 09/03/2024

CGMP/Finished Pharmaceuticals/Adulterated

FDA orangebook
11 Sep 2024

September 10, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA orangebook
11 Sep 2024
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