Chicago Indoor Garden - 606992 - 12/29/2022

… of your firm’s corrective actions in response to our Warning Letters FY2020-HAFE-WL-04 and CHI-4-16. Based on our … you have addressed the violation(s) contained in these Warning Letters. Future FDA inspections and regulatory …

Quick Guide to Web Resources

… Compliance Actions (Biologics) Enforcement Actions (CBER) Warning Letters Untitled Letters (CBER ) Biological Product Deviations Biological …

5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC

… 1932a found at: www.fda.gov/ReportAnimalAE . FDA Issues Warning Letters:   FDA, FTC Continue Joint Effort to Protect … Illegally Selling Copycat Delta-8 THC Food Products Warning Letters:   Warning Letters and Test Results for …

Important Patient and Consumer Information About Regenerative Medicine Therapies

… at ocod@fda.hhs.gov . This web posting  reemphasizes the warning to consumers in FDA’s July 2020 Consumer Alert : … Products Warnings and Safety Notifications FDA sends warning to companies for offering unapproved umbilical cord … Products Including Stem Cells and Exosomes FDA Warning Letters FDA/CBER Untitled Letters FDA letter to clinics and …

FDA Roundup: March 19, 2024

… the FDA is taking to address these issues. The FDA issued warning letters to three entities that describe violations related to … entities to fully address the violations described in the warning letters and will take additional steps as …

Coronavirus (COVID-19) Update: December 1, 2020

… the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to … care provider. The FDA has also posted the following warning letters for unapproved and misbranded products related to …

Coronavirus (COVID-19) Update: July 9, 2021

… the FDA’s effort to protect consumers, the agency issued warning letters to 12 firms for offering for sale in the U.S. … with their health care provider. The firms that received warning letters are: maskshell.com   Manhattan Stitching …

Coronavirus (COVID-19) Update: Daily Roundup April 16, 2020

… investigational new drug applications. The FDA issued warning letters to Fishman Chemical of North Carolina, LLC ., and Dr. … or indexed. Although neither product identified in today’s warning letters made claims about use in people, the agency …

FDA Steps Up Efforts to Protect Consumers from Food Allergens

… food allergens. Since March 2020, the FDA has sent warning letters to eight registered food facilities that have … food is distributed.  Also, recently, the agency sent a warning letter to Whole Foods Market for a series of major …

Caution Consumers: Honey-based or Honey-flavored Syrup Products May Pose Health Risk

… 12, 2022, the U.S. Food and Drug Administration posted  warning letters to companies that are violating federal law by … enhancement claims . Additionally, the agency issued warning letters and stopped products from being imported into …

FDA Roundup: September 17, 2024

… the absence of sleep apnea. On Friday, the FDA issued six warning letters to manufacturers and retailers for the sale or … trade show. The FDA also announced the issuance of warning letters to five online retailers for selling …

FDA Roundup: May 26, 2023

… news from around the agency:  On Thursday, the FDA issued warning letters to firms responsible for two popular flavored, … Breeze products. The e-cigarette firms that received warning letters today make, distribute or import tobacco …

Regulatory Actions by FDA Relating to Raw Milk and Raw Milk Products

… actions by FDA may be accessed at the following links. Warning Letters Warning Letter to White Egret Farm (Austin, TX) 12/15/2004 …

Office of Compliance and Biologics Quality (OCBQ)

… FDA References for Enforcement and Compliance Actions FDA Warning Letters (Searchable by Year Posted) Untitled Letters (CBER ) FDA Inspection Classification Database …

Muscle Sports Products, LLC - 625731 - 09/23/2022

… WARNING LETTER CMS # 625731 Dear Mr. Mancuso: This is to … produced salts (e.g., hordenine HCl). FDA recently sent warning letters to several firms selling dietary supplements …

Compliance Actions (Biologics)

… Issued by CBER Regulatory Actions Issued by CBER Search Warning Letters and Responses with Search Form BIMO/Team Biologics/Internet Surveillance/Other Untitled Letters Regarding Advertising & Promotional Labeling for …

FDA Roundup: May 3, 2024

… efforts.  On Wednesday, the FDA announced the issuance of warning letters to 14 online retailers for selling unauthorized … e-cigarette products popular among youth. These warning letters cite the sale of disposable e-cigarette …

FDA Roundup: June 14, 2024

… available. On Thursday, the FDA announced the issuance of warning letters to six online retailers for selling unauthorized … authorization from FDA. On Tuesday, the FDA posted warning letters to four companies marketing the unapproved …

Labeling & Nutrition Guidance Documents & Regulatory Information

… Safety Alerts (Policies, Enforcement Reports, Alerts) For warning letters and other letters, see the  FOIA Electronic Reading Room and FDA Warning Letters Label Claims Letter of Enforcement Discretion …

Aspartame and Other Sweeteners in Food

… additional studies of saccharin and the presence of a warning label on saccharin-containing products until such a warning could be considered unnecessary. Since then, more … the GRAS notices submitted to the FDA. The FDA's response letters on such high purity steviol glycosides are available …

FDA Provides Update on the Cronobacter Prevention Strategy

… industry. This includes the recent issuance of three warning letters to infant formula firms in August 2023. The letters reinforce the importance of instituting and …

FDA Roundup: September 15, 2023

… On Thursday, the FDA issued warning letters to 15 online retailers and three manufacturers and/or … illegally sold a product to an underage purchaser. The warning letters cite a range of popular and youth-appealing …

Advancing the Development of Safe and Effective Regenerative Medicine Products

… has included taking compliance actions, including numerous warning and untitled letters, and pursuing enforcement action for serious … Since December 2019, the agency has issued more than 350 letters to manufacturers, clinics, and health care providers, …

HFP FOIA Electronic Reading Room

… Make a FOIA Request HHS Policy for Records Management FDA Warning Letters Food Guidance Documents Compliance Program Guidance … Allergens/Whole Foods Product Responsive Records re: CFSAN Warning letter (PDF - 1MB) February 24, 2021 Letter to …

Pasha Food Distribution USA, Inc. - 607108 - 05/18/2020

… WARNING LETTER May 18, 2020   Re: CMS # 607108 Dear Mr. … very small importers because, while your response includes letters from your (b)(4) suppliers, these letters do not address the suppliers’ compliance with the …