advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide.
21 CFR Part 211 · Current Good Manufacturing Practice for Finished Pharmaceuticals
§ 211.34 Consultants
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 211.34
Form FDA 483 observations citing this section, fiscal years 2009–2021 (Drugs).
- Consultant Records 14
Warning letters citing § 211.34
4 FDA warning letters since 2017 cite this section :
- Grupo Quimico SRL 30 Apr 2024
- Sure-Biochem Laboratories, LLC 24 Mar 2023
- Vilvet Pharmaceutical 25 Feb 2019
- Actavis Laboratories FL, Inc. 1 Feb 2019
FDA guidance that cites § 211.34
- Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection draft 6 Mar 2026
- Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations 2 Oct 2006
Amendment history
Federal Register documents that created or amended this section.
- 43 FR 45077 29 Sept 1978