Are you violating 21 CFR 211.160(b) ?

1. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

Reasons for the above violation:

The firm's laboratory sampling plans and testing methods were not scientifically sound.

The firm collected non-representative samples of their water system.

Water from the water system is used in the formulation of topical over-the-counter (OTC) drug products.

The water system monitoring procedure provided during the inspection did not discuss the number, location, or frequency of samples to collect.

The firm told the investigator that they typically take a sample from the water system from a single location near the XYZ component.

The sampling frequency and locations, which did not include sampling from any point of use, were not appropriate to provide substantive data to promptly detect system variability.

Furthermore, microbiological testing used for water analysis was deficient.

They have not shown the test methods were adequate for determining the quality of the water in view of its intended use in the drug products.

Furthermore, they lacked appropriate limits, routine testing, or validated methods for detecting the presence of B. cepacia in the water system.

Their microbiological testing is insufficient to assure that their water system is suitable for its intended use.

Additionally, FDA analysis of samples collected from the farm's water system recovered too-numerous-to-count results for multiple total microbial count tests.