Specified Microorganisms and More - FDA Warning Letter

During an inspection of Suretec Innovations, LLC, conducted from March 2 to 5, 2026, the FDA identified significant violations of CGMP requirements for finished pharmaceuticals. According to the FDA, the company’s procedures, facilities, and controls were insufficient to ensure the identity, strength, quality, and purity of its drug products. The main deficiencies concerned inadequate testing of incoming materials, serious shortcomings in microbiological testing, insufficient investigations of deviations, and an inadequately resourced and ineffective quality unit.

Inadequate Testing and Qualification of Incoming Materials

The company did not perform adequate identity testing on all incoming components, including the API used in the manufacture of its OTC product. Instead, it relied extensively on suppliers’ certificates of analysis without demonstrating the reliability of the suppliers’ testing through appropriate initial qualification and periodic re-evaluation.

As a result, there was insufficient evidence that the incoming materials actually met the required specifications for identity, strength, quality, and purity before being used in manufacturing. The FDA also noted that the company’s post-inspection actions did not include sufficient component-specific acceptance criteria, defined test methods, or results from retrospective confirmatory testing.

Particularly Serious Deficiencies in Microbiological Testing

The FDA found that the company had not ensured that every batch of its drug products was adequately tested before release for the absence of objectionable microorganisms. The non-compendial microbiological test method used for this purpose was inadequate and had not been validated. Among other deficiencies, the method lacked:

• appropriate incubation times;
• demonstrated method suitability;
• suitable positive and negative controls; and
• complete method validation.

Consequently, the company could not reliably determine whether batches already released and distributed in the United States met microbiological requirements and were suitable for use by consumers. The company’s commitment to validate USP <61> and <62> methods for future testing did not, in the FDA’s view, address the need to retrospectively assess the quality of batches already manufactured that were still within their expiry period.

The FDA considered the repeated microbiological results above the established limits in the system used by the company to be particularly critical. Material from this system was used as a component in drug manufacturing even though several microbial counts had exceeded the permitted limits. Rather than fully investigating the results and determining the root cause, the company continued to use the material for manufacturing. The resulting drug products were subsequently released and distributed. The FDA therefore identified a potential risk that contaminated or microbiologically unsuitable drug products may have reached the market.

The company also lacked sufficiently defined microbiological alert and action limits, appropriate sampling frequencies, and clear acceptance criteria for the system. The procedures submitted after the inspection did not demonstrate that the previous out-of-limit results had been adequately investigated or that the potentially affected batches had been assessed retrospectively.

Inadequate Investigations of Deviations and OOS/OOL Results

The Quality Unit did not thoroughly investigate several abnormal microbiological results. There was no adequate, traceable assessment of the possible root causes, the affected materials and batches, or the potential impact on products that had already been released.

According to the FDA, inadequate investigations can result in:

• failure to identify the true root causes;
• ineffective corrective and preventive actions;
• recurrence of quality problems; and continued manufacture or distribution of potentially affected drug products.

A systematic retrospective risk assessment of the affected product batches was not evident.

Deficiencies in the Quality Unit and Quality System

According to the FDA, the Quality Unit lacked sufficient authority, responsibilities, and resources to effectively oversee CGMP-compliant manufacturing. In particular, the FDA identified deficiencies in the following areas:

• missing or inadequate written procedures for production and process controls, including qualification of the system used;
• no adequate stability testing program to establish or support storage conditions and expiry dates;
• insufficient definition of the Quality Unit’s responsibilities and controls;
• insufficient numbers of qualified personnel for manufacturing, processing, packaging, and holding operations;
• incomplete final batch review and disposition before release; and
• inadequate oversight and approval of deviation and failure investigations.

Overall, the FDA considered the company’s quality systems insufficiently robust to ensure consistent compliance with established requirements.

Violations Relating to Drug Registration and Listing

In addition to the CGMP violations, the FDA found that the company manufactured KleenLine Alcohol-Free Sanitizing Wipes for a private label distributor but had not properly listed the product under the distributor’s name and labeler code in the FDA database. The required drug listing was therefore incomplete, and the product was considered misbranded from a regulatory perspective.

The submitted labeling for Hand Sanitizing Alcohol-Free Wipes also appeared to bear the trade name of a different private label distributor. The labeling therefore needed to be corrected and aligned with the actual registration and drug listing information.

Overall Assessment

The most serious deficiencies concerned inadequate microbiological control of both the manufactured batches and the system used in the manufacturing process. In particular, the continued use of material despite repeated microbial counts above the permitted limits, followed by the release of products manufactured with that material, represented a significant quality risk. Together with the lack of validated microbiological methods, inadequate investigations, and weak Quality Unit oversight, these deficiencies meant that the company had not established adequate controls to ensure the quality and safety of its drug products.