§1.511. What FSVP must I have if I am importing a food subject to certain requirements in the dietary supplement current good manufacturing practice regulation?
21 C.F.R. § 1.511
Importers subject to certain requirements in the dietary supplement current good manufacturing practice regulation. If you are required to establish specifications under § 111.70(b) or (d) of this chapter with respect to a food that is a dietary supplement or dietary supplement component you import for further manufacturing, processing, or packaging as a dietary supplement, and you are in compliance with the requirements in §§ 111.73 and 111.75 of this chapter applicable to determining whether the specifications you established are met for such food, then for that food you must comply with the requirements in §§ 1.503 and 1.509, but you are not required to comply with the requirements in § 1.502, §§ 1.504 through 1.508, or § 1.510. This requirement does not limit your obligations with respect to part 111 of this chapter or any other laws enforced by FDA.
Importers whose customer is subject to certain requirements in the dietary supplement current good manufacturing practice regulation. If your customer is required to establish specifications under § 111.70(b) or (d) of this chapter with respect to a food that is a dietary supplement or dietary supplement component you import for further manufacturing, processing, or packaging as a dietary supplement, your customer is in compliance with the requirements of §§ 111.73 and 111.75 of this chapter applicable to determining whether the specifications it established are met for such food, and you annually obtain from your customer written assurance that it is in compliance with those requirements, then for that food you must comply with the requirements in §§ 1.503, 1.509, and 1.510, but you are not required to comply with the requirements in § 1.502 or §§ 1.504 through 1.508.
Other importers of dietary supplements—
General. If the food you import is a dietary supplement and neither paragraph (a) or (b) of this section is applicable, you must comply with paragraph (c) of this section and the requirements in §§ 1.503, 1.505(a)(1)(ii) through (iv), (a)(2), and (b) through (d), and 1.508 through 1.510, but you are not required to comply with the requirements in §§ 1.504, 1.505(a)(1)(i), 1.506, and 1.507. This requirement does not limit your obligations with respect to part 111 of this chapter or any other laws enforced by FDA.
Use of approved foreign suppliers.
You must establish and follow written procedures to ensure that you import foods only from foreign suppliers that you have approved based on the evaluation conducted under § 1.505 (or, when necessary and appropriate, on a temporary basis from unapproved foreign suppliers whose foods you subject to adequate verification activities before importing the food). You must document your use of these procedures.
You may rely on an entity other than the foreign supplier to establish the procedures and perform and document the activities required under paragraph (c)(2)(i) of this section provided that you review and assess that entity's documentation of the procedures and activities, and you document your review and assessment.
Foreign supplier verification procedures. You must establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the foods you import.
Determination of appropriate foreign supplier verification activities—
General. Except as provided in paragraph (c)(4)(iii) of this section, before importing a dietary supplement from a foreign supplier, you must determine and document which verification activity or activities listed in paragraphs (c)(4)(ii)(A) through (D) of this section, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the foreign supplier is producing the dietary supplement in accordance with processes and procedures that provide the same level of public health protection as those required under part 111 of this chapter. This determination must be based on the evaluation conducted under § 1.505.
Appropriate verification activities. The following are appropriate supplier verification activities:
Onsite audits as specified in paragraph (c)(5)(i)(A) of this section;
Sampling and testing of a food as specified in paragraph (c)(5)(i)(B) of this section;
Review of the foreign supplier's relevant food safety records as specified in paragraph (c)(5)(i)(C) of this section; and
Other appropriate supplier verification activities as specified in paragraph (c)(5)(i)(D) of this section.
Reliance upon determination by other entity. You may rely on a determination of appropriate foreign supplier verification activities in accordance with paragraph (c)(4)(i) of this section made by an entity other than the foreign supplier if you review and assess whether the entity's determination regarding appropriate activities (including the frequency with which such activities must be conducted) is appropriate based on the evaluation conducted in accordance with § 1.505. You must document your review and assessment, including documenting that the determination of appropriate verification activities was made by a qualified individual.
Performance of foreign supplier verification activities.
Except as provided in paragraph (c)(5)(ii) of this section, for each dietary supplement you import under paragraph (c) of this section, you must conduct (and document) or obtain documentation of one or more of the verification activities listed in paragraphs (c)(5)(i)(A) through (D) of this section before importing the dietary supplement and periodically thereafter.
Onsite auditing. You conduct (and document) or obtain documentation of a periodic onsite audit of your foreign supplier.
(1) An onsite audit of a foreign supplier must be performed by a qualified auditor.
(2) The onsite audit must consider the applicable requirements of part 111 of this chapter and include a review of the foreign supplier's written food safety plan, if any, and its implementation (or, when applicable, an onsite audit may consider relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States).
(3) If the onsite audit is conducted solely to meet the requirements of paragraph (c)(5) of this section by an audit agent of a certification body that is accredited in accordance with subpart M of this part, the audit is not subject to the requirements in that subpart.
(4) You must retain documentation of each onsite audit, including the audit procedures, the dates the audit was conducted, the conclusions of the audit, any corrective actions taken in response to significant deficiencies identified during the audit, and documentation that the audit was conducted by a qualified auditor.
(5) The following inspection results may be substituted for an onsite audit, provided that the inspection was conducted within 1 year of the date by which the onsite audit would have been required to be conducted:
(i) The written results of appropriate inspection of the foreign supplier for compliance with the applicable requirements in part 111 of this chapter conducted by FDA, representatives of other Federal Agencies (such as the USDA), or representatives of State, local, tribal, or territorial agencies; or
(ii) The written results of an inspection by the food safety authority of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States, provided that the food that is the subject of the onsite audit is within the scope of the official recognition or equivalence determination, and the foreign supplier is in, and under the regulatory oversight of, such country.
Sampling and testing of the food. You must retain documentation of each sampling and testing of a dietary supplement, including identification of the food tested (including lot number, as appropriate), the number of samples tested, the test(s) conducted (including the analytical method(s) used), the date(s) on which the test(s) were conducted and the date of the report of the testing, the results of the testing, any corrective actions taken in response to detection of hazards, information identifying the laboratory conducting the testing, and documentation that the testing was conducted by a qualified individual.
Review of the foreign supplier's food safety records. You must retain documentation of each record review, including the date(s) of review, the general nature of the records reviewed, the conclusions of the review, any corrective actions taken in response to significant deficiencies identified during the review, and documentation that the review was conducted by a qualified individual.
Other appropriate activity. (1) You may conduct (and document) or obtain documentation of other supplier verification activities that are appropriate based on foreign supplier performance and the risk associated with the food.
(2) You must retain documentation of each activity conducted in accordance with paragraph (c)(5)(i)(D)(1) of this section, including a description of the activity, the date on which it was conducted, the findings or results of the activity, any corrective actions taken in response to significant deficiencies identified, and documentation that the activity was conducted by a qualified individual.
Reliance upon performance of activities by other entities.
Except as specified in paragraph (c)(5)(ii)(B) of this section, you may rely on supplier verification activities conducted in accordance with paragraph (c)(5)(i) by another entity provided that you review and assess the results of these activities in accordance with paragraph (c)(5)(iii) of this section.
You may not rely on the foreign supplier or employees of the foreign supplier to perform supplier verification activities, except with respect to sampling and testing of food in accordance with paragraph (c)(5)(i)(B) of this section.
Review of results of verification activities. You must promptly review and assess the results of the verification activities that you conduct or obtain documentation of under paragraph (c)(5)(i) of this section, or that are conducted by other entities in accordance with paragraph (c)(5)(ii) of this section. You must document your review and assessment of the results of verification activities. If the results show that the foreign supplier is not producing the dietary supplement in accordance with processes and procedures that provide the same level of public health protection as those required under part 111 of this chapter, you must take appropriate action in accordance with § 1.508(a). You are not required to retain documentation of supplier verification activities conducted by other entities, provided that you can obtain the documentation and make it available to FDA in accordance with § 1.510(b).
Independence of qualified individuals conducting verification activities. There must not be any financial conflicts of interest that influence the results of the verification activities set forth in paragraph (c)(5)(i) of this section, and payment must not be related to the results of the activity.
Notes, amendments, and revision history
Amendments
[80 FR 74340, Nov. 27, 2015, as amended at 81 FR 25327, Apr. 28, 2016]
Source
Source: 80 FR 74340, Nov. 27, 2015, unless otherwise noted.
Authority
Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.
Source
Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.
Amendments
[80 FR 74340, Nov. 27, 2015, as amended at 81 FR 25327, Apr. 28, 2016]