Time is of the Essence: Regulatory Administrative Action Letters

Human Cell, Tissue, and Cellular and Tissue-based Products (HCT/Ps) establishments are regulated under FDA’s Center of Biologics Evaluation & Research (CBER). HCT/Ps establishments are under strict scrutiny, where the distribution of potentially contaminated HCT/Ps are of great concern. If the FDA observes any critical violations of 21 CFR 1271, the FDA could issue a regulatory administrative action letter. The establishment should consider contacting FDA compliance consultants to help resolve the issues.

What are some different types of Regulatory Administrative Action Letters?

The purpose of the regulatory administrative action letters is to prevent the spread of communicable disease through HCT/Ps manufactured by establishments in violation of the regulations. The different types of regulatory administrative action letters issued by FDA CBER that will be discussed in this article are:

• FDA Administrative License Action Letters
• Orders of Retention, Recall, Destruction, and Cessation of Manufacturing Related to HCT/Ps

Administrative License Action Letters

The objective of these lettersis to cancelor suspend the license and to withdraw the authorization to introduce or deliver biological products into interstate commerce. In some cases, CBER will allow the manufacturer to achieve compliance before initiating revocation proceedings and issue a Notice of Intent to Revoke License Letter instead of a License Revocation Letter. Administrative License Action Letters should be taken seriously, and a strategic plan should be developed prior to contacting the FDA. FDA compliance consultants are knowledgeable on the time allotted for responding. Time is of the essence and the manufacturer should act quickly.

Orders of Retention, Recall, Destruction, and Cessation of Manufacturing Related to HCT/Ps

A formal letter from CBER ordering a manufacturer to retain, recall, destruct or cease requires the manufacturer to adhere to such order. The purpose of this letter is to prevent the transmission of communicable disease through contaminated HCT/Ps. The FDA can issue an Order of Retention, Recall, Destruction, or Cessation of Manufacturing if any conditions listed in 21 CFR 1271.440 occur. The following conditions are:

• If the FDA believes that an HCT/P was manufactured in violation of the regulations, hence cannot provide sufficient protections against the risk of communicable disease transmission
• If the HCT/P is a contaminated source of dangerous infection to humans
• If an establishment is in violation of the regulations and does not provide sufficient protections against the risks of communicable disease transmission

If any of the findings above exist and the establishment fails to comply with such order, the FDA is authorized to take possession and/or destroy the HCT/Ps manufactured in violation of the regulations. In addition, the FDA may give an Order to Cease which requires the establishment to stop all manufacturing until it is in compliance with Part 1271. FDA compliance consultants will advise that these types of orders are the most serious and will only allow five working days to comply with the order. In case of recalls, the establishment’s quality assurance department should take action according to the standard operating procedures manual or contact FDA compliance consultants who have experience contacting consignees for recall purposes.

The establishment’s high-level management should work diligently with the quality assurance department to address FDA’s concerns. Partnering with regulatory experts, such as FDA compliance consultants can help you take the necessary actions in the required time given by the FDA.

Author Information

Christina Sanchez Miller, MPH has over 20 years of management, biologics, quality assurance and research experience in the medical field. She is a published author in scientific books, papers and has presented at several international conferences. Christina has developed medical applications in the biologics field. Her experience includes operations and consulting in FDA Adverse Event Reporting, FDA Product Deviation Reporting, FDA 483s, cGTPs, infection control, certified ISO Class 5, 7, 8 development and maintenance, QIC and auditing.

BRG is a global scientific & regulatory consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, combination products and in FDA regulatory affairs. BRG is an FDA compliance consulting group focusing on BLA, FDA Regulatory Action Letters, and Biologics Combination Products.  The opinions and statements in this blog are those of the authors and do not necessarily reflect those of BRG. This blog is based on personal experience and reviews of information publicly available or identified in other database searches.

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