FDA Warning Letter

Results: 186



#Item
41Quality / Health / Pharmaceutical industry / Management / Quality management system / Form FDA 483 / Design controls / Medical device / Validation / Medicine / Technology / Food and Drug Administration

2013 Annual FDA Medical Device Quality System Data FDA Form 483 Observations and Warning Letter Citations

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Source URL: www.fda.gov

Language: English
42Piperazines / Otitis / Pediatrics / Otologicals / Audiology / Otitis externa / Ciprofloxacin / Otitis media / Otalgia / Medicine / Health / Otology

Warning Letter" Ciprodex (ciprofloxacin) sterile otic suspension

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Source URL: www.fda.gov

Language: English
43Pharmacology / Clinical pharmacology / Therapeutics / United States Public Health Service / Cough medicine / Oncology Drug Advisory Committee / FDA Warning Letter / Food and Drug Administration / Pharmaceutical sciences / Clinical research

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007P[removed]Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee; Notice of Meeting

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Source URL: www.fda.gov

Language: English - Date: 2007-08-14 16:44:15
44Food and Drug Administration / Quality / FDA Warning Letter

Chapter 6 Judicial Actions

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Source URL: www.fda.gov

Language: English
45Food and drink / Dietary supplements / Energy drink / Caffeine / Federal Food /  Drug /  and Cosmetic Act / FDA Warning Letter / Ephedra / Hydroxycut / Medicine / Food and Drug Administration / Health

FACT SHEET The Facts about Caffeine in Dietary Supplements Caffeine-containing products that are labeled as dietary supplements are regulated by FDA. •

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Source URL: www.crnusa.org

Language: English - Date: 2013-04-02 17:01:50
46Safety / Center for Food Safety and Applied Nutrition / Dietary supplement / Food safety / Federal Food /  Drug /  and Cosmetic Act / Office of Regulatory Affairs / FDA Warning Letter / Nutrition Labeling and Education Act / Applied Food Technologies / Food and Drug Administration / Health / Medicine

United States Government Accountability Office GAO Report to the Chair, Subcommittee on Agriculture, Rural Development, Food

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Source URL: www.gao.gov

Language: English - Date: 2011-09-29 09:12:37
47Pharmaceutical sciences / Federal Food /  Drug /  and Cosmetic Act / Center for Biologics Evaluation and Research / Premarket approval / Food and Drug Administration Modernization Act / FDA Warning Letter / Food and Drug Administration / Medicine / Health

[removed]Federal Register / Vol. 72, No[removed]Tuesday, October 23, [removed]Notices V. Responsiveness Criteria Each application submitted will be

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Source URL: www.fda.gov

Language: English - Date: 2007-10-23 07:44:52
48Food law / Pharmaceutical sciences / Pharmaceuticals policy / Class I recall / Federal Food /  Drug /  and Cosmetic Act / Mammography Quality Standards Act / FDA Warning Letter / Regulation of food and dietary supplements by the U.S. Food and Drug Administration / Food and Drug Administration / Medicine / Health

The Enforcement Story Fiscal Year 2006 ________________________________________________________________________________ DEFINITIONS COMPLIANCE ACHIEVEMENT: The observed repair, modification, or adjustment

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Source URL: www.fda.gov

Language: English
49International child abduction / FDA Warning Letter / Food and Drug Administration

GENERIC CIVIL COMPLIANCE AND ENFORCEMENT PROCESS Noncompliance should be resolved at the lowest possible level. The goal is compliance, not enforcement. The options for addressing and resolving noncompliance should be p

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Source URL: itepsrv1.itep.nau.edu

Language: English - Date: 2008-08-01 17:38:36
50Health / New Drug Application / Form FDA 483 / Clinical trial / Criticism of the Food and Drug Administration / Prescription Drug User Fee Act / Food and Drug Administration / Pharmaceutical sciences / Research

Warning Letter: Replidyne

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Source URL: www.fda.gov

Language: English
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