21 CFR Subpart O
Records
June 25, 2020
§
112.162
Where must I store records?
§
112.161
What general requirements apply to records required under this part?
§
112.163
May I use existing records to satisfy the requirements of this part?
§
112.164
How long must I keep records?
§
112.165
What formats are acceptable for the records I keep?
§
112.166
What requirements apply for making records available and accessible to FDA?
§
112.167
Can records that I provide to FDA be disclosed to persons outside of FDA?
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