Warning letter

Warning letters Seizure of products Product confiscation Product destruction Public admonition Fines... 

B. Warning letters, seizures, injunctions, and prosecutions under Sections 302, 303, and 304. 

At present, marketers who make xmsubstantiated health claims are not penalized when the FDA warns them to stop. The FDA should be permitted to generate civil penalties in connection with warning letters. 

After inspection, the inspector prepares a detailed Establishment Inspection Report (EIR). This is the FDA s primary record for the inspection. Time is given to the manufacturer to respond to the deficiencies found and recorded on Form FDA-483. Failure to comply with satisfactory resolution of the deficiencies found will result in the FDA sending out a Warning Letter notifying the manufacturer to comply. If the manufacturer is unable to resolve the deficiency after the deadline set by the FDA, the FDA may proceed to prosecute the manufacturer with an injunction. The injunction is a court order called Consent Decree, and the manufacturer may be required to cease operations until the problem is rectified (see Exhibit 10.4). 

Regulatory authorities inspect GMP facilities to ensure compliance to GMP. The FDA carries out surveillance and compliance inspections. A system-based approach is adopted quality, facilities and equipment, materials, production, packaging and labeling, and laboratory control. Deficiencies are reported on Form FDA-483, which may lead to a warning letter and consent decree if unresolved. 

The Team Biologics report is known as an Establishment Inspection Report, which consists of a list of observations recorded on a Form 483. In the Findings section, both products and processes are discussed and various processes are rated. Inspections of both products and the establishment focus on systematic evaluation of quality. Inspection Reports may recommend warning letters, notice of intent to revoke licenses, or civil or criminal legal action. 

Pride of Workmanship and Continuous Learning Frequent corrective actions take away the pride of workmanship from production operators and other staff in industrial operations. In addition, FDA s penalty system (e.g., Warning Letters) is often construed to be directed at industrial operations. The ability to distinguish between common cause and special cause variability can be an important element in the FDA s penalty system and facilitate a move towards a continuous improvement approach and help build/improve the pride of workmanship dimension. 

FDA/Center for Food Safety and Applied Nutrition. Sample warning letter on androstenedione. http //vm.cfsan.fda.gov/ dms/andltr.html (accessed 4-11-2004). 

In fiscal year 2005, the FDA field office conducted 1437 cGMP inspections, resulting in 15 warning letters, six injunctions, and one seizure. These enforcement actions are discussed later in this chapter. Data for the years 2000-2005 are set forth in Figures 1 and 2. 

Examples of situations in which the FDA may be expected to issue a warning letter include ... 

A warning letter is distinguishable from a notice of violation, also called an untitled letter. An untitled letter cites violations that do not meet the threshold of regulatory significance for a warning letter, but the FDA has a need nevertheless to communicate. Unlike a warning letter, an untitled letter does not include a warning statement that failure to take prompt correction may result in enforcement action and does not evoke a mandated FDA follow-up. Further, the untitled letter requests (rather than requires) a written response (from the manufacturer) within a reasonable amount of time (e.g., Please respond within 45 days ). 

The FDA is likely to bypass sending a Warning Letter in certain circumstances. According to Chapter 4 of the FDA Regulatory Procedures Manual, the following violations are likely to result in an enforcement action without necessarily issuing a warning letter ... 

The violations, under Title 18 U.S.C. 1001, are intentional and willful acts that once having occurred cannot be retracted. Also, such a felony violation does not require prior notice. Therefore, Title 18 U.S.C. 1001 violations are not suitable for inclusion in warning letters. 

Individual versus Corporate Liability Introducing an adulterated product into interstate commerce is a strict liability crime that can be enforced against individuals in positions of sufficient authority and responsibility as well as their company. Persons at risk are those who, at minimum,20 fail to take adequate measures to prevent the cGMP violations. As such, warning letters and other communications are often directed at presidents and CEOs as well as their companies. As stated by the U.S. Supreme Court21 in 1964, just two years after the FDCA as we know it was passed ... 

Section 305 Proceedings Due to the nature of the inspection process, a company that the FDA deems is in violation of the cGMPs should not be surprised when a warning letter or more elevated enforcement techniques are implemented. Even so, the FDA sometimes issues a formal form of notice that criminal charges will be brought by what is called a Section 305 notice. 

Inadequate process definition, controls, and oversight Warning letter >1... 

C Repeat observations—direct product impact Failure to meet warning letter commitments Consent decree >100... 

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