(FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374) "Factory Inspection". Form FDA 483,...

recommendations to FDA Centers. All district office must use the CMS to submit the warning letter recommendation, the Form FDA 483 that supports the alleged...

February 2010 US FDA. "Warning Letter" UCM066113 US FDA. "Warning Letter" UCM069041 US FDA. Form FDA 483 issued to L. Perrigo Co., dated 11/07/2008. Observation...

About Vision. August 24, 2006. "FDA Statement on Preliminary Bausch & Lomb Inspection Findings." May 16, 2006. Form FDA-483 May 15, 2006. Associated Press...

facility inspections. Inspection observations are documented on Form 483. In June 2018, the FDA released a statement regarding new guidelines to help food...

December 2022. "FDA slaps Dr. Reddy's with a Form 483 - FiercePharma". www.fiercepharmamanufacturing.com. "Dr Reddy's API plant receives USFDA 483 with nine...

Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C...

lowering or eliminating their fat content. The Food and Drug Administration (FDA) approved olestra for use in the US as a replacement for fats and oils in...

the original (PDF) on 2011-07-08. Retrieved 2010-06-14. "www.accessdata.fda.gov" (PDF). Reid JM, Storch EA, Murphy TK, Bodzin D, Mutch PJ, Lehmkuhl H...

States Food and Drug Administration (FDA). In February 2007, Cardinal Health signed a consent decree with the FDA which promised procedures to guarantee...

and the FDA's black-box warning: determining a rational public policy in the absence of sufficient evidence". The Virtual Mentor. 14 (6): 483–488. doi:10...

Administration (FDA). 20 August 2013. Retrieved 23 January 2021. "FDA approves new HIV treatment" (Press release). U.S. Food and Drug Administration (FDA). Archived...

routine inspections of manufacturers and imported products, issuance of the FDA 483, complaint investigations, audits of recalls, collections of samples, and...

European Food Safety Authority (EFSA) and US Food and Drug Administration (FDA), and by international reviewers, such as the Joint FAO/WHO Expert Committee...

digital pill to be approved by the United States Food and Drug Administration (FDA), a version of aripiprazole (Abilify) manufactured by Otsuka Pharmaceutical...

June 2013. "April 2012 Inspectional Observations (form 483)", U.S. Food and Drug Administration (FDA), Vaccines, Blood & Biologics, 12 April 2012, retrieved...

and Drug Administration (FDA). In February 2008, the TGA implemented a boxed warning for the drug. In January 2013, the FDA issued a safety communication...

product contamination cases. In 2006, the U.S. Food and Drug Administration (FDA) banned seven dietary supplement products that claimed to include E. longifolia...

transplantation, pruritus or fatigue. Ursodiol and obeticholic acid are FDA-approved for the treatment of primary biliary cholangitis. UDCA use is associated...

prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics". U.S. FDA. May 23...

the pipeline ?". European Journal of Medical Research. 12 (9): 483–495. PMID 17933730. "FDA Approves HIV Drug Etravirine". Associated Press. 18 January 2008...

approved by the Food and Drug Administration (FDA) for medical use in the United States in 1967. The topical form of methenamine for treatment of hyperhidrosis...

§342(a)(7). 21 U.S.C. §374. FDA: "Investigations Operations Manual," 5.2.3.4 – Annotation of the FDA 483, last visited June 29, 2010. FDA: The Food Defect Action...

and Drug Administration (FDA) to warn of the increased risk of suicidality during antidepressant treatment. According to the FDA, the heightened risk of...

BORON NITRIDE". EWG. Retrieved 2023-07-26. "UNII - 2U4T60A6YD". precision.fda.gov. Retrieved 2023-07-26. "NSF International / Nonfood Compounds Registration...

PMID 27784557. "FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer"...

database sources include: EPA DSSTox U.S. Food and Drug Administration (FDA) Human Metabolome Database Journal of Heterocyclic Chemistry KEGG KUMGM LeadScope...

with hepatocellular carcinoma(HCC), the most common form of liver cancer, in October 2007, and FDA approval for this indication followed in November 2007...

in 1990 by the American Candy Company after the FDA discovered that PCA's peanut butter exceeded the FDA tolerance level for aflatoxin, a mold-derived toxin...

a controversial debate surrounding the drug's efficacy, during which two FDA review panel members resigned in protest, eteplirsen received accelerated...