CGMP Consultants Recommended in FDA Warning Letters


In a review of the latest one hundred (100) FDA Warning Letters issued as of May 17, 2019, nineteen (19) included the section header “CGMP Consultants Recommended” within the content of the letter, followed by these statements:

 “Based upon the nature of the violations we identified at your firm, we strongly recommend engaging consultants qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements.” and “Your use of consultants does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.”

Additional content beyond these “boilerplate” statements appears in some letters, such as:

“We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and that the consultant evaluates the completion and effectiveness of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.”

If you still plan to manufacture drugs, we also recommend a qualified consultant with drug manufacturing experience perform a comprehensive audit of your drug production operation for CGMP compliance and evaluate the completeness and effectiveness of any CAPA you have implemented before engaging in drug production.”

These recommendations were typically offered in response to violations of CGMP related to data integrity practices as applicable to the manufacturer or laboratory testing of pharmaceuticals. 

21 CFR 211.34 calls for consultants to have “sufficient education, training, and experience, or any combination thereof”.  Performance Validation offers the services of a cadre of qualified professionals who are knowledgeable and experienced in a broad spectrum of CGMP compliance issues within the pharmaceutical and medical device industries.  Records of qualifications including education, training, and experience for each of our team members is maintained by Performance Validation and is available for review as required by 21 CFR 211.34.