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<article xlink="http://www.w3.org/1999/xlink" dtd-version="1.0" article-type="healthcare" lang="en"><front><journal-meta><journal-id journal-id-type="publisher">IJCRR</journal-id><journal-id journal-id-type="nlm-ta">I Journ Cur Res Re</journal-id><journal-title-group><journal-title>International Journal of Current Research and Review</journal-title><abbrev-journal-title abbrev-type="pubmed">I Journ Cur Res Re</abbrev-journal-title></journal-title-group><issn pub-type="ppub">2231-2196</issn><issn pub-type="opub">0975-5241</issn><publisher><publisher-name>Radiance Research Academy</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">4004</article-id><article-id pub-id-type="doi"/><article-id pub-id-type="doi-url">http://dx.doi.org/10.31782/IJCRR.2021.SP253</article-id><article-categories><subj-group subj-group-type="heading"><subject>Healthcare</subject></subj-group></article-categories><title-group><article-title>Strategic Analysis of Warning Letters Issued by United State Food and Drug Administration to Pharmaceutical Companies Globally&#13;
</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>H.</surname><given-names>Tiwaskar G.</given-names></name></contrib><contrib contrib-type="author"><name><surname>G.</surname><given-names>Pise A.</given-names></name></contrib><contrib contrib-type="author"><name><surname>A.</surname><given-names>Pise S.</given-names></name></contrib><contrib contrib-type="author"><name><surname>P</surname><given-names>Bhardwaj</given-names></name></contrib></contrib-group><pub-date pub-type="ppub"><day>26</day><month>05</month><year>2021</year></pub-date><volume>ar</volume><issue>me</issue><fpage>118</fpage><lpage>123</lpage><permissions><copyright-statement>This article is copyright of Popeye Publishing, 2009</copyright-statement><copyright-year>2009</copyright-year><license license-type="open-access" href="http://creativecommons.org/licenses/by/4.0/"><license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution (CC BY 4.0) Licence. You may share and adapt the material, but must give appropriate credit to the source, provide a link to the licence, and indicate if changes were made.</license-p></license></permissions><abstract><p>In pharmaceutical companies, the term __ampersandsignldquo;Quality__ampersandsignrdquo; has special importance. It deals with the patient__ampersandsignrsquo;s healthcare as well as their safety. To maintain this __ampersandsignldquo;Quality__ampersandsignrdquo; there are various regulatory authorities around the world and these are according to the different countries such as the United States Food __ampersandsignamp; Drug Administration (USFDA) for the US, Medicine __ampersandsignamp; Healthcare Products Regulatory Agency (MHRA) for the UK, Therapeutic Good Administration (TGA) for Australia, etc. These regulatory authorities conduct an audit to identify the common issues that arise in pharmaceutical companies in a variety of sectors such as manufacturing quality, prescription drug promotion, immediate office, etc. and the authorities are responsible for giving a detailed report of violations of regulations in the form of CODE OF FEDERAL REGULATIONS (CFR) in the form of Warning letters. In this paper, we will mainly focus on the manufacturing quality and the common issues that arise in FDA483 for the U.S.A.&#13;
</p></abstract><kwd-group><kwd>Audit</kwd><kwd> FDA483</kwd><kwd> Quality</kwd><kwd> Regulatory affairs</kwd><kwd> Warning letters</kwd><kwd> Guidelines</kwd></kwd-group></article-meta></front></article>
