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Remember that the 483 report and EIR will be available under freedom of information legislation, so it is vital for you and your company to have a copy of the FDA establishment inspection report. FDA directs its investigators to fax the form and a summary of findings to the Division of Field Investigations before completing an establishment inspection report when a foreign inspection shows significant, system-wide quality system deviations. investigations reviewed was due to the failure of the assay for oxycodone in oxycodone/aspirin tablets," Berry wrote in the Establishment Inspection Report ( |
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