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  1. The primary assessment for companies as to whether they are subject to the Preventive Control Rule is the requirement to register with FDA as a food facility, known as Registration of Food Facilities. If your facility is required to register, the facility is subject to the Preventive Control Rules, unless the facility qualifies for an exemption ...

  2. Dec 22, 2023 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 117.257 Contents of an order to withdraw a qualified facility exemption. (2) Conditions or conduct associated with a qualified facility that are material to the safety of the food manufactured, processed, packed, or held at such facility.

  3. Dec 22, 2023 · 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). Sec. 117.475 Records documenting the supply-chain program. (a) The records documenting the supply-chain program are subject to the requirements of subpart F of this part.

  4. Dec 22, 2023 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 117.7 Applicability of subparts C, D, and G of this part to a facility solely engaged in the storage of unexposed packaged food. (a) Applicability of subparts C and G. Subparts C and G of this part do not apply to a facility solely ...

  5. Dec 22, 2023 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 117.165 Verification of implementation and effectiveness. (a) Verification activities. You must verify that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards.

  6. Dec 22, 2023 · 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). Sec. 117.160 Validation. (a) You must validate that the preventive controls identified and implemented in accordance with § 117.135 are adequate to control the hazard as ...

  7. Dec 22, 2023 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 117.4 Qualifications of individuals who manufacture, process, pack, or hold food. (a) Applicability. (1) The management of an establishment must ensure that all individuals who manufacture, process, pack, or hold food subject to ...

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