Form FDA 483 (English Wikipedia)

Analysis of information sources in references of the Wikipedia article "Form FDA 483" in English language version.

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18web.archive.org

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2bioquality.biz

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biotech.about.com

"Phillips, Theresa. About.com: Biotech / Biomedical; "Why Fear Form-483?" (24-Nov-2008)". Archived from the original on 2011-04-07. Retrieved 2010-04-05.

barryafriedmanphdllc.com

Friedman, Barry (April 24, 2013). "FDA CDER Most Frequent Form FDA 483 Observations Fiscal Year 2012". Barry A. Friedman, PhD LLC (Blog). Retrieved 22 Dec 2019.

bioquality.biz

contractpharma.com

Roth, Gil Y. Contract Pharma; "Glossary of Terms - Form 483" (Volume 12, Number 3) p. 83

fda.gov

fdatransparencyblog.fda.gov

"FDA: "Tell Us Your Ideas: How Should FDA Inform the Public About Inspection Results"". Archived from the original on 2010-04-02. Retrieved 2010-04-05.

fdazilla.com

blog.fdazilla.com

"FDAzilla | How to Respond to a Form FDA 483". Archived from the original on 2011-04-27. Retrieved 2011-03-04.

fdazilla.com

"FDAzilla's 483s index search". Archived from the original on 2010-10-29. Retrieved 2010-09-09.

findpharma.com

appliedclinicaltrialsonline.findpharma.com

"Goebel, Paul W.; Whalen, Matthew D.; and Khin-Maung-Gyi, Felix. Applied Clinical Trials Online; "What a Form 483 Really Means" (01-Sep-2001)". Archived from the original on 2011-07-11. Retrieved 2010-04-05.

in-pharmatechnologist.com

Taylor, Nick . in-Pharma Technologist.com; "Ignore a form 483? Not wise say FDA" (26-Feb-2009)

pharmaceuticalonline.com

Unger, Barbara (6 December 2019). "FDA FY2019 Drug Inspection Observations And Trends". Pharmaceutical Online. VertMarkets. Retrieved 22 Dec 2019.

pharmtech.com

blog.pharmtech.com

"Rios, Maribel. PharmTech Talk; "FDA Begins Enforcing Deadlines on Form 483 Responses" (15-Sep-2009)". Archived from the original on 2010-04-06. Retrieved 2010-04-05.

web.archive.org

FD&C Act, "Sec. 704. (21 USC §374) Factory Inspection"
FDA; "Guidance for Industry - Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP"
"Goebel, Paul W.; Whalen, Matthew D.; and Khin-Maung-Gyi, Felix. Applied Clinical Trials Online; "What a Form 483 Really Means" (01-Sep-2001)". Archived from the original on 2011-07-11. Retrieved 2010-04-05.
"Phillips, Theresa. About.com: Biotech / Biomedical; "Why Fear Form-483?" (24-Nov-2008)". Archived from the original on 2011-04-07. Retrieved 2010-04-05.
BioQuality, "INSPECTIONAL ANNUAL REVIEW, A Decade of FDA Form 483 Notices of Deficiency" (Volume 15, Issue 1) p. 5 Archived 2009-07-05 at the Wayback Machine. ISSN 1090-2759
"Rios, Maribel. PharmTech Talk; "FDA Begins Enforcing Deadlines on Form 483 Responses" (15-Sep-2009)". Archived from the original on 2010-04-06. Retrieved 2010-04-05.
BioQuality, "News You Can Use: Reading Between the Lines of FDA Letters" (Volume 16, Issue 4/5) p. 2. Archived 2009-07-05 at the Wayback Machine ISSN 1090-2759
"FDAzilla | How to Respond to a Form FDA 483". Archived from the original on 2011-04-27. Retrieved 2011-03-04.
Shapiro, Jeffrey K., and Wesoloski, Brian J. "FDA’s Regulatory Scheme for Human Tissue A Brief Overview
U.S. Code of Federal Regulations, Title 21, Part 1271, Subpart F
Coukell, Allan. "Protecting Consumers from Adulterated Drugs"
FDA: "Investigations Operations Manual", SUBCHAPTER 1.1 - ENGLISH LANGUAGE REQUIREMENT FOR FDA DOCUMENTS
FDA: "Investigations Operations Manual", EXHIBIT 5-5
FDA; "(OEI) Development and Maintenance Procedures"
FDA: "Guidant Corporation, 483 Inspectional Observations, St Paul, Minnesota, dated 12/15/2005 - 02/09/2006"
FDA; "ORA FOIA Electronic Reading Room"
"FDAzilla's 483s index search". Archived from the original on 2010-10-29. Retrieved 2010-09-09.
"FDA: "Tell Us Your Ideas: How Should FDA Inform the Public About Inspection Results"". Archived from the original on 2010-04-02. Retrieved 2010-04-05.

worldcat.org