LegalFix

§ 111.255 - What is the requirement to establish a batch production record?

Copy with citation
Copy as parenthetical citation

You must prepare a batch production record every time you manufacture a batch of a dietary supplement;

Your batch production record must include complete information relating to the production and control of each batch;

Your batch production record must accurately follow the appropriate master manufacturing record and you must perform each step in the production of the batch; and

You must make and keep batch production records in accordance with subpart P of this part.

LegalFix

Copyright ©2024 LegalFix. All rights reserved. LegalFix is not a law firm, is not licensed to practice law, and does not provide legal advice, services, or representation. The information on this website is an overview of the legal plans you can purchase—or that may be provided by your employer as an employee benefit or by your credit union or other membership group as a membership benefit.

LegalFix provides its members with easy access to affordable legal services through a network of independent law firms. LegalFix, its corporate entity, and its officers, directors, employees, agents, and contractors do not provide legal advice, services, or representation—directly or indirectly.

The articles and information on the site are not legal advice and should not be relied upon—they are for information purposes only. You should become a LegalFix member to get legal services from one of our network law firms.

You should not disclose confidential or potentially incriminating information to LegalFix—you should only communicate such information to your network law firm.

The benefits and legal services described in the LegalFix legal plans are not always available in all states or with all plans. See the legal plan Benefit Overview and the more comprehensive legal plan contract during checkout for coverage details in your state.

Use of this website, the purchase of legal plans, and access to the LegalFix networks of law firms are subject to the LegalFix Terms of Service and Privacy Policy.

We have updated our Terms of Service, Privacy Policy, and Disclosures. By continuing to browse this site, you agree to our Terms of Service, Privacy Policy, and Disclosures.
§ 111.255 - What is the requirement to establish a batch production record?