US Manufacturer buys ‘Pharmaceutical Water’ in Grocery Store

During an inspection of a US manufacturer of OTC products in March 2025, the FDA identified serious violations of GMP requirements for finished medicinal products. Among other issues, the manufacturer had purchased the water used in its production process from a grocery store. This resulted in a warning letter from the FDA.

No microbiological quality testing

In the case of a disinfectant for hospitals, which is used to prepare the skin before surgery, the manufacturer had released several batches without testing them for microbiological quality. One batch, which was manufactured in September 2024 and delivered to a children's hospital, was only tested for chemical parameters and sensory properties.
In response to Form FDA 483, it was stated that the product contains bactericidal substances and therefore testing for objectionable microorganisms is not necessary. The FDA considers this justification insufficient, as no scientific evidence has been provided to support this claim and no retrospective testing of batches already delivered has been carried out.
The FDA is now requesting complete chemical and microbiological specifications and test methods for testing finished products. In addition, chemical and microbiological testing of retained samples is required, as well as a summary of the resulting measures and any recalls.

Deficiencies in the testing and procurement of raw materials

The FDA had determined that no complete identity testing of the ingredients had been carried out. Instead, the company relied solely on the suppliers' CoAs without verifying their analysis results. The use of water from a grocery store as a raw material, which was only tested organoleptically (colour, smell and appearance), was also mentioned here.
The FDA now requires a comprehensive and independent review of the entire material system. This review will assess whether all suppliers of active ingredients, excipients, packaging materials and containers are qualified and whether all materials have been provided with appropriate expiry or re-test dates. In addition, it will be determined whether the existing incoming inspections are adequate to effectively prevent the use of unsuitable materials.
Furthermore, the chemical and microbiological specifications used in the testing and release of each incoming batch of material must be presented. This also includes a description of how batches will be tested for identity, content, quality and purity in the future. If tests based on suppliers' CoAs are to be accepted, it must be explained how their reliability is first validated and then regularly verfied. Regardless of this, at least one specific identity test must always be carried out per batch.
In addition, a complete risk assessment must be submitted for all products that are still within their shelf life and could be affected by one of the aforementioned contaminations. Preventive measures must also be defined to ensure the safety of the supply chain in future. These include, in particular, the complete qualification of raw material suppliers and the exclusion of the aforementioned contaminants.

Inadequate quality management system

The FDA considers the manufacturer's quality system to be unable to ensure compliance with GMP requirements. The FDA refers here to the ‘Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations’ and recommends consulting an experienced GMP consultant to comprehensively remedy the identified deficiencies and ensure future compliance.

The Warning Letter to the US manufacturer of OTC products can be found on the FDA website.