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FDAs Pre-Approval Inspection (PAI) Program and How to
by CDRD DiGIulio Cited by 3 As part of the inspection, they will audit records, equipment, procedures, and the batch records submitted in the application as well as inspect the
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Plaintiffs First Request For Production of Documents
1. Unless otherwise specified, the documents called for by these document requests are documents in your possession, custody or control that were applicable,
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Plaintiffs Objections and Responses to Defendants First
Plaintiff objects to the extent the request seeks the production of documents that are not relevant or likely to lead to the discovery of admissible evidence.
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