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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR1002.31]
See Related Information on Preservation and inspection of records. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER J--RADIOLOGICAL HEALTH

PART 1002 -- RECORDS AND REPORTS

Subpart D--Manufacturers' Records

Sec. 1002.31 Preservation and inspection of records.

(a) Every manufacturer required to maintain records pursuant to this part, including records received pursuant to 1002.41, shall preserve such records for a period of 5 years from the date of the record.

(b) Upon reasonable notice by an officer or employee duly designated by the Department, manufacturers shall permit such officer or employee to inspect appropriate books, records, papers, and documents as are relevant to determining whether the manufacturer has acted or is acting in compliance with Federal standards.

(c) Upon request of the Director, Center for Devices and Radiological Health, a manufacturer of products listed in table 1 of 1002.1 shall submit to the Director, copies of the records required to be maintained by paragraph (b) of 1002.30.

[38 FR 28625, Oct. 15, 1973, as amended at 53 FR 11254, Apr. 6, 1988; 60 FR 48386, Sept. 19, 1995]

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