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3 Common Reasons Why Manufacturers Get FDA Warning Letters

By June 6, 2018March 30th, 2023No Comments

Here are some examples of common violations brought up in past warning letters issued by the FDA, and how the SWK Enterprise Management bundle, powered by Sage, can help prevent these compliance breaches


The Food and Drug Administration (FDA) is the federal agency that regulates manufacturers of consumable products. These include food and beverage, cosmetic and personal care products, dietary supplements and other nutraceuticals, pharmaceuticals and medical devices. If a manufacturer is found to be in violation of compliance, then they will receive a warning letter from the FDA.

Warning letters outline the primary breaches observed by FDA inspectors, though they will state in the body of content whether the manufacturer has committed additional unlisted errors. Within each letter, the FDA explains the nature of the violation and will request that the subject take all possible steps to rectify the stated infractions and any that may not have been listed. It is the responsibility of the manufacturer to review and address all possible instances of noncompliance. Failure to do so can cause the FDA to request law enforcement personnel to seize products deemed adulterated and/or charges be brought against the offending manufacturer.

Here are some examples of common violations brought up in past warning letters issued by the FDA, and how the SWK Enterprise Management bundle, powered by Sage, can help prevent these compliance breaches:

1. Violating the FDA Good Manufacturing Practices

Good Manufacturing Practices (GMP) are a critical component of FDA regulations governing manufacturers in multiple industry verticals. Current Good Manufacturing Practice (CGMP) represent the FDA’s current best practice standards for a given industry. These practices may be subject to change at any given stage (though after a significant period of deliberation by the FDA), however, there are several key points that consistently remain vital throughout each iteration.

The most important obligation under most versions of GMP for every manufacturing sector affected by this regulation is the implementation and maintenance of a system of production and processing controls. A majority of provisions included in GMP guidelines are related in some form to the establishment of such a system, or the failure to do so. Consequently, many violations originate from an organizations inability to follow through on adopting production and processing controls or employing them inadequately at one or more stages.

Violations of GMP can be found in almost every industry that falls under the FDA’s regulatory jurisdiction, though the sectors with some of the most common offenders are food and beverage and dietary supplements. This is due in part to the perishable nature of the raw materials and end products that are involved in these areas, which is a major factor in the regulations governing the production processes used. One of the most important components in establishing compliance in these sectors is preventing disease and harmful ingredients from reaching consumers.

Examples of warning letters issued to operators within these industries include several sent to dairy product manufacturers, confectionery manufacturers, bottled water processing plants, and dietary supplement production centers. Common violations include human input processes and facility conditions being deemed unsanitary, as well as a lack of inspection of such items that may have led to such conditions to appear. The latter point is especially important, as a significant factor in compliance is ensuring follow-through of regulation-related procedures consistently. Enterprise Management allows you to establish checkpoints at critical control stages to ensure best practices are applied at every junction.

2. Violating Labeling, Branding & Classification Laws

Product identification is a major obligation imposed by the FDA, and failure to do so in a manner which is considered legally adequate by the agency can result in serious consequences. Certain sectors – such as cosmetic, nutraceutical and pharmaceutical manufacturing – are heavily scrutinized for how their end products are marketed and sold in the US. A significant part of this regulation is how ingredients are labeled on products, as well as how the FDA is notified of their inclusion and how they may affect the product’s classification.

The FDA maintains strict definitions for regulated products as per the Food Drug and Cosmetic Act (FD&C Act, or simply the Act) and later legislation that created more exact segmentation for consumables. In particular, certain marketing claims or ingredients can cause a product to be ruled mislabeled. This will cause that product to either lose its classification or to be defined as something else entirely (most often a drug) that changes the nature of its marketing.

There are also firm rules regarding labeling for certain types of raw materials used in batch processing, such as potential allergens. In food and beverage manufacturing, even if such ingredients were not directly included in a product, merely utilizing them within the same facility requires labeling indicating so on all end product packaging to warn consumers of the possible danger. There are additional guidelines for defining ingredients in a legally acceptable manner, i.e. one that would be commonly recognized by consumers.

Dairy, seasoning and dressing, and confectionery manufacturers may often be the target of such warning letters when they do not include adequate information on their package labeling. Dietary and health supplements (including those derived from cannabis), personal care products, and finished pharmaceuticals are also common offenders of mislabeled products in terms of branding and classification. Many of these types of mislabeling violations are solved when manufacturers apply accurate raw material data towards end production stages and preliminary distribution tasks that allow for consistently informative product labeling. The Enterprise Management bundled solution SWK enables you to capture this data and apply it through the appropriate fields to deliver precise product information.

3. Violating Documentation & Recordkeeping Laws


SWK Technologies developed the only turnkey, bundled manufacturing solution available to help process manufacturers and wholesalers comply with FDA regulations for traceability requirements internally and across the supply chain



Though documentation and recordkeeping regulations fall partly under established GMP provisions for many industries, the archiving and maintenance of processing information constitutes a major component of compliance that extends beyond production controls. Besides providing evidence that such controls exist, process documentation allows you to capture more accurate data necessary to meeting compliance and to trace instances of noncompliance back to the origin point. This information is integral to fulfilling several regulation-related tasks.

FDA documentation regulations specifically outline required procedures for establishing written instructions for compliance-related processing actions as well providing audit trails for these tasks as they are carried out. These records deliver a roadmap for before and after production practices are put into place to enable full end-to-end supply chain visibility, including for user input at critical processing stages that affect end product compliance. This data in turn allows the FDA to prove that you are fulfilling compliance and to identify where a process may have suffered an error, as well as to inform the agency whether you may have ignored the situation or if it had been genuinely overlooked.

Nearly all industries regulated by the FDA have some form of a requirement for documenting compliance-related processes, however, certain sectors have more stringent reporting obligations for specific situations. Pharmaceutical preparation and medical device manufacturers must submit all data on a product that led to concluding its safety for human consumption or application. They must also submit similar data for every new introduction or change to that product (new ingredients, manufacture change, etc.), including for addressing potential breaches of compliance, such as a device malfunctioning. Maintaining compliance with electronic documentation and reporting regulations requires capturing and managing the most accurate data on relevant processing functions. Implementing the Enterprise Management bundle for supply chain visibility delivers this information and the evidence necessary to demonstrate compliance.

The SWK Sage X3 Compliance Software Bundle Allows You to Fulfill FDA Regulations for Manufacturing

These are only a fraction of the sectors that have been issued warning letters by the FDA and even emerging industries – such as cannabis processing and distribution – may fall under the jurisdiction of these regulations. Several of these violations resulted from deploying adequate data and demonstrating sufficient evidence to the FDA of compliance commitment. Implementing SWK’s Sage X3 Compliance Software bundle for manufacturing and supply chain compliance will allow you to capture and apply the data you need to oblige the FDA’s regulatory requirements.

Download one of our free E-books to learn more about this bundled manufacturing and supply chain solution and how it can help you meet FDA compliance in your industry.

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