FDA RANITIDINE SAMPLES TESTING AND MANUFACTURER COMMUNICATIONS REGARDING NDMA

Original Request: Any and all identifying information for the 180 ranitidine samples tested by FDA including, but not limited to, manufacturer name, lot number, dosage, form, expiry date, etc. • Any and all testing information for the 180 ranitidine samples including, but not limited to, test method, testing conditions, test results, etc. • Any and all communications from manufacturers indicating their product contained NDMA above the ADI level including, but not limited to, manufacturer name, lot number, dosage, form, expiry date, testing information and test results. If there are any fees for searching or copying these records, please inform me if the cost will exceed $50.00. If you deny any or all of this request, please cite each specific exemption you feel justifies the refusal to release the information and notify me of the appeal procedures available to me under the law.
Tags: Pharma, EIR, 2021