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About 811 results for "Fda Good Manufacturing Practices"

Issues raised by US FDA for Pithampur unit resolved: Glenmark ...

The plant had received Form 483 observations for its current good manufacturing practices at the plant Business Standard, 1 week ago
Federal Register

FDA Issues Industry Draft Guidance on Data Integrity, Current Good Manufacturing Practice

WASHINGTON, April 15 -- The Department of Health and Human Services published the following notice in the Federal Register from the Food and Drug Administration : Data Integrity and Compliance With Current Good Manufacturing Practice; Draft ...
 Equities.com2 weeks ago Follow the Data: FDA Addresses cGMPs for Data Integrity Issues in Draft Guidance  National Law Review1 day ago FDA Issues Revised Draft Industry Guidance for Immunogenicity Testing of Therapeutic Protein Products  Equities.com5 days ago FDA Issues Guidance for Hospitals and Health Systems Engaged in Drug Compounding  JD Supra1 week ago

CPC Scientific Passes Fourth FDA Inspection

CPC Scientific has announced that the CPC Good Manufacturing Practice (GMP) facility inHangzhou, Chinahas successfully passed its fourth U.S. Food and Drug Administration (FDA) inspection.No Form 483 observations were issued. Passing this ...
 American Pharmaceutical Outsourcing3 weeks ago CPC Scientific Successfully Passes 4th U.S. FDA Inspection  Bloomberg3 weeks ago

Imprimis Pharmaceuticals Registers its Texas Facility with the FDA as an Outsourcing Facility

_ The ImprimisRx TX facility will make and distribute compounded drugs according to current good manufacturing practices (cGMP), which are the same standards used for the manufacture of FDA-approved drugs. ImprimisRx TX will initially distribute the ...
 Sys-Con Media2 weeks ago IMPRIMIS PHARMACEUTICALS : Registers its Texas Facility with the FDA as an Outsourcing Facility  4 Traders2 weeks ago Austrianova Facility Commissioned For GMP Manufacturing  BioSpace4 days ago Imprimis Registers Its Texas Facility With The FDA As An Outsourcing Facility  BioSpace2 weeks ago
Federal Register

USFDA Warns Sri Krishna Pharma for CGMP Norm Violations

The USFDA detailed significant violations of current good manufacturing practice (CGMP) at Sri Krishna's Unit II finished formulation plant in Nacharam, Hyderabad. April 28, 2016 By Denice Cabel cGMP Sri Krishna Pharma USFDA ...
 PharmaAsia2 days ago Quality Engineer -Manufacture Midmark Corporation  EnvironmentGuru.com1 week ago US FDA warns Sri Krishna Pharma for CGMP rule violations  Business Line1 week ago FDA warns another Indian drug maker on serious quality control lapses  StatNews.com1 week ago

Alembic gets four FDA observations for Panelav facility

The US drug regulator raises its concerns on manufacturing practices at the Panelav facility Hyderabad: Shares of Ahmedabad-based Alembic Pharmaceuticals Ltd fell as much as 7% to Rs.525 on BSE in early trades on Monday as the US Food and Drug ...
 Livemint.com1 week ago

FDA issues final rule on sanitary transportation of food

Food and Drug Administration (FDA) recently issued the sixth of the seven major final rules required by the Food Safety Modernization Act (FSMA), one governing the safe transportation of food that actually has its origins in the Sanitary Food ...
 Lexology5 days ago A&B Healthcare Week in Review  JD Supra1 week ago Toxic chemicals in shampoo and beauty products are not regulated by the FDA  Sott.net1 week ago Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. III, Issue 6  Lexology1 week ago

NeuroDerm Reveals Removal Of Import Alert By FDA On Infusion Pumps

NeuroDerm Ltd. (Nasdaq: NDRM ) disclosed the removal of FDA alert on infusion pumps used in the clinical trials ND0612. The company said it was informed by Canè S.p.A., the third party manufacturer of the infusion pumps that they were removed from ...
 Benzinga.com1 week ago Good News for NeuroDerm as the FDA Removes Import Alert of Infusion Pumps Used in ND0612 Clinical Trials  BioSpace1 week ago

Glenmark receives 3 observations from USFDA

The USFDA conveys its concerns on manufacturing practices for Glenmark's formulations facility at Pithampur Hyderabad: Glenmark Pharmaceuticals Ltd on Thursday said it received three observations from US Food and Drug Administration (FDA) for its ...
 Livemint.com1 week ago

WHEATON to Present Educational Session on Parenteral Drug Packaging at INTERPHEX 2016

The session, to be held April 26 , will detail critical practices and standards the FDA enforces for parenteral drug packaging MILLVILLE, N.J.--(BUSINESS WIRE)-- WHEATON® announces that Global Market Manager Jeffrey Reid will present the ...
 Equities.com1 week ago WHEATON : to Present Educational Session on Parenteral Drug Packaging at INTERPHEX 2016  4 Traders1 week ago Key Elements to Consider when Packaging Parenteral Products  PharmaceuticalProcessing4 days ago
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