FDA Establishment Inspection Reports and Warning Letters

Another source to check for standards and expectations that may not be spelled out in published guidelines is enforcement documents, such as Establishment Inspection Reports (EIRs) and Warning Letters. For example, results of periodic inspections by FDA investigators of manufacturing facilities, laboratories, and clinical investigative sites worldwide can help identify areas of operations currently under particular scrutiny. Warning Letters from the FDA to companies or clinicians can also provide vital background on alleged violations observed during establishment inspections, outlining agency concerns and corrective actions required. Warning Letters also address issues such as wording in drug labeling and advertising, as well as problem areas in the behavior of company sales and marketing staff, such as promotion of unapproved indications or dissemination of misleading cost comparisons with competitors. In addition to clarifying requirements and specific criteria for compliance, the content of these enforcement documents often signals shifts in regulatory initiatives that may affect future business.

Databases

Warning Letters and Notice of Violation Letters to Pharmaceutical Companies. 1997- . URL: http://www.fda.gov/cder/warn. Documents in this database are limited to correspondence issued from FDA Headquarters. Many originate from the Division of Drug Marketing, Advertising, and Communication (DDMAC). The collection is browsable in separate lists assembled for each year from 1997 forward. Annual lists, organized in reverse chronological order by month, identify product brand name or other topic (such as "Site Inspection''), company, and the FDA Headquarters Division initiating the action. Each tabular entry is hyperlinked to the full text of the letter, although portions of the content may be redacted (edited) to mask confidential information. There is no separate search capability provided for targeted searches of this database. The search engine offered on the main CDER Web page will, however, retrieve Warning Letters for specified companies and products—along with numerous other documents unrelated to notices of violation.

Warning Letters. 1996- . URL: http://www.fda.gov/foi/warning. htm. The FDA Web site offers a separate database of Warning Letters originating, for the most part, from the Agency's Field Offices (rather than Headquarters—see above). This collection archives correspondence retrospective to November 1996 and does include a few documents originating from Headquarters Divisions, such as the CBER. The opening menu offers a choice of separate, browsable lists of letters, organized by company, subject, issuing office, or date. There is also an option to search either the most recent year or the entire collection ofletters via a form. The search form enables precise retrieval by one or more factors, such as specific company name, issuing FDA office, subject terms assigned by the sender, and (theoretically) keywords found in the full text of letters. (Caution: Incomplete results of text word queries indicate that this capability is not fully functional on the FDA Web site.) Hyperlinks in this database provide access to both PDF and HTML versions of letters. In 2003, the FDA also began posting responses to Warning Letters, subject to the sender's permission.

The FOI Online Web site (cited previously) also enables keyword searching of a huge retrospective collection of FDA Warning Letters, as well as FDA Guidance documents. Both of these compilations complement those offered on the FDA web site. Since the database supplier is also a document delivery service, the online file serves as a catalog of materials stored in-house after being obtained through Freedom of Information Act provisions. This means that items not separately listed or readily searchable on the FDA Web site are indexed at FOI Online. For example, the database provides separate bibliographic records for FDA EIRs, searchable by company name, establishment location, and inspection date ranges.

Newsletters and Journals

The Gold Sheet: Pharmaceutical and Biotechnology Quality Control. 1967- . Chevy Chase, MD: F-D-C Reports. Monthly. This newsletter focuses on discussions of quality control policies and procedures and compliance issues in the United States. It also reports on significant FDA enforcement activities related to GMP, such as Warning Letters. The Gold Sheet is available by subscription in hardcopy format or, alternatively, through a Web-based platform for searching. The full text of both current and back issues is also directly searchable in the F-D-C Reports database online (see below).

Drug GMP Report. Falls Church, VA: Washington Business Information. Monthly. The Drug GMP Report, as its title implies, focuses on regulatory developments affecting production quality control. With the objective of making compliance with FDA policies easier, each monthly issue highlights GMP enforcement trends revealed in EIRs and Warning Letters, as well as emerging issues related to certification procedures and electronic data requirements. The Drug GMP Report is one of several hardcopy current awareness publications from Washington Business Information. This publisher's other drug-related titles include: The Food and Drug Letter (1976 forward, updated biweekly), Generic Line (1984 forward, updated biweekly), and Washington Drug Letter (1969 forward, updated weekly). The full text of the latest issues of all of these titles, as well as retrospective archives of past issues, is incorporated into the FDAnews database online.

Good Clinical Practice Journal (GCP Journal). 1994- . Richmond, Surrey, UK: PJB Publications. Monthly. Articles in this journal focus on identifying and clarifying compliance issues and on assisting with interpretation and implementation of national and international regulations that affect global clinical trials.

Books

Good Clinical Practice: A Question and Answer Reference Guide. Waltham, MA: PAREXEL International, 2005. This 420-page spiral bound guide provides answers to more than 400 GCP-related questions. Additional reference material in the volume includes relevant portions of Title 21, Code of Federal Regulations, selected ICH guidelines, and the European Clinical Trials Directive.

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