IR @ Nirma University
Keeping in tune the global developments we are creating an institutional repository using DSpace Software (Digital Library Software). We are archiving institutional knowledge like, faculty papers, theses, and dissertations in PDF format at DSpace. Students can access this digital information anywhere in the campus.
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http://10.1.7.192:80/jspui/handle/123456789/9843| Title: | Food and Drug Administration Warning Letters |
| Authors: | Pambhar, Malay N. Patel, Vishvha M. |
| Keywords: | PPR01058 B. Pharm Project Report Pharmaceutical Analysis Food and Drug Administration (FDA) Regulatory Violations 17BPH049 17BPH106 FDA warning letter Quality Assurance Clinical Trials |
| Issue Date: | May-2021 |
| Publisher: | Institute of Pharmacy, Nirma University, A'bad |
| Series/Report no.: | PPR01058; |
| Abstract: | FDA warning letters are authorized FDA notice identifying significant regulatory breaches. Letters are usually accomplished in project to make sure that they are read and dealt with as soon as possible. An FDA warning letter, like and FDA 483. If the reason for the FDA warning letter is important enough, the FDA can extend the deadline. It is mandatory to correct the breaches. Here within this report the discussion of transgression in the branches of quality assurance, clinical trials, and stability |
| URI: | http://10.1.7.192:80/jspui/handle/123456789/9843 |
| Appears in Collections: | B. Pharm Project Reports |
Files in This Item:
| File | Description | Size | Format | |
|---|---|---|---|---|
| PPR01058.pdf | PPR01058 | 2.61 MB | Adobe PDF |  View/Open |
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