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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 2]
[CITE: 21CFR117]


Subpart F - Requirements Applying to Records That Must Be Established and Maintained

Sec. 117.301 Records subject to the requirements of this subpart.

(a) Except as provided by paragraphs (b) and (c) of this section, all records required by this part are subject to all requirements of this subpart.

(b) The requirements of § 117.310 apply only to the written food safety plan.

(c) The requirements of § 117.305(b), (d), (e), and (f) do not apply to the records required by § 117.201.

Sec. 117.305 General requirements applying to records.

Records must:

(a) Be kept as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records;

(b) Contain the actual values and observations obtained during monitoring and, as appropriate, during verification activities;

(c) Be accurate, indelible, and legible;

(d) Be created concurrently with performance of the activity documented;

(e) Be as detailed as necessary to provide history of work performed; and

(f) Include:

(1) Information adequate to identify the plant or facility (e.g., the name, and when necessary, the location of the plant or facility);

(2) The date and, when appropriate, the time of the activity documented;

(3) The signature or initials of the person performing the activity; and

(4) Where appropriate, the identity of the product and the lot code, if any.

(g) Records that are established or maintained to satisfy the requirements of this part and that meet the definition of electronic records in § 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this part, but that also are required under other applicable statutory provisions or regulations, remain subject to part 11 of this chapter.

Sec. 117.310 Additional requirements applying to the food safety plan.

The owner, operator, or agent in charge of the facility must sign and date the food safety plan:

(a) Upon initial completion; and

(b) Upon any modification.

Sec. 117.315 Requirements for record retention.

(a)(1) All records required by this part must be retained at the plant or facility for at least 2 years after the date they were prepared.

(2) Records that a facility relies on during the 3-year period preceding the applicable calendar year to support its status as a qualified facility must be retained at the facility as long as necessary to support the status of a facility as a qualified facility during the applicable calendar year.

(b) Records that relate to the general adequacy of the equipment or processes being used by a facility, including the results of scientific studies and evaluations, must be retained by the facility for at least 2 years after their use is discontinued (e.g., because the facility has updated the written food safety plan (§ 117.126) or records that document validation of the written food safety plan (§ 117.155(b)));

(c) Except for the food safety plan, offsite storage of records is permitted if such records can be retrieved and provided onsite within 24 hours of request for official review. The food safety plan must remain onsite. Electronic records are considered to be onsite if they are accessible from an onsite location.

(d) If the plant or facility is closed for a prolonged period, the food safety plan may be transferred to some other reasonably accessible location but must be returned to the plant or facility within 24 hours for official review upon request.

Sec. 117.320 Requirements for official review.

All records required by this part must be made promptly available to a duly authorized representative of the Secretary of Health and Human Services for official review and copying upon oral or written request.

Sec. 117.325 Public disclosure.

Records obtained by FDA in accordance with this part are subject to the disclosure requirements under part 20 of this chapter.

Sec. 117.330 Use of existing records.

(a) Existing records (e.g., records that are kept to comply with other Federal, State, or local regulations, or for any other reason) do not need to be duplicated if they contain all of the required information and satisfy the requirements of this subpart. Existing records may be supplemented as necessary to include all of the required information and satisfy the requirements of this subpart.

(b) The information required by this part does not need to be kept in one set of records. If existing records contain some of the required information, any new information required by this part may be kept either separately or combined with the existing records.

Sec. 117.335 Special requirements applicable to a written assurance.

(a) Any written assurance required by this part must contain the following elements:

(1) Effective date;

(2) Printed names and signatures of authorized officials;

(3) The applicable assurance under:

(i) Section 117.136(a)(2);

(ii) Section 117.136(a)(3);

(iii) Section 117.136(a)(4);

(iv) Section 117.430(c)(2);

(v) Section 117.430(d)(2); or

(vi) Section 117.430(e)(2);

(b) A written assurance required under § 117.136(a)(2), (3), or (4) must include:

(1) Acknowledgement that the facility that provides the written assurance assumes legal responsibility to act consistently with the assurance and document its actions taken to satisfy the written assurance; and

(2) Provision that if the assurance is terminated in writing by either entity, responsibility for compliance with the applicable provisions of this part reverts to the manufacturer/processor as of the date of termination.

Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.
Source: 80 FR 56145, Sept. 17, 2015, unless otherwise noted.