A review on USFDA warning letter and violation observed in Pharmaceutical Industry
Keywords:
cGMP, USFDA warning letter, Pharmaceutical Industry, violation of rules
Abstract
A review on USFDA observation and finding while inspection of pharmaceutical the present review provides some important, significant observation and measure of compliance. USFDA is a regulatory body governing health products which are made (in or outside USA) and marketed in united States of America. Significant deviation from cGMP and significant violation from cGMP for both API Facility and formulations. Strictly compliance requirements under 21 Code of federal regulations
References
1.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
2.https://www.law.cornell.edu/cfr/text/21/chapter-I
3.http://www.fda.gov/ICECI/EnforcementActions/
4. http://www.fda.gov/ICECI/EnforcementActions/ApplicationIntegrityPolicy/u...
5.http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
6.http://www.accessdata.fda.gov/scripts/warningletters/wlFilterByCompany.cfm
2.https://www.law.cornell.edu/cfr/text/21/chapter-I
3.http://www.fda.gov/ICECI/EnforcementActions/
4. http://www.fda.gov/ICECI/EnforcementActions/ApplicationIntegrityPolicy/u...
5.http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
6.http://www.accessdata.fda.gov/scripts/warningletters/wlFilterByCompany.cfm
Published
2016-12-01
How to Cite
[1]
khoja, S., khoja, S., chauhan, P. and Khoja, F. 2016. A review on USFDA warning letter and violation observed in Pharmaceutical Industry. PharmaTutor. 4, 12 (Dec. 2016), 33-36.
Section
Articles
