Warning Letter: Matheson Tri-Gas

November 9, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Dallas, TX (Nov. 7)-The US Food and Drug Administration has posted a Warning Letter from its Dallas District office to Matheson Tri-Gas, Inc.

Dallas, TX (Nov. 7)-The US Food and Drug Administration has posted a Warning Letter (http://www.fda.gov/foi/warning_letters/g6096d.htm) from its Dallas District office to Matheson Tri-Gas, Inc. (Parsippany, NJ, www.mathesontrigas.com). The three-page letter, dated Sept. 12, detailed findings of inspections, in March and April of this year, of a Matheson medical gas facility in Houston, and reviewed the company's April 19 response to the inspectors' Form 483 observations.

The Warning includes three citations, noting shortcomings in:

  • establishing specifications, standards, sampling plans, and test procedures to assure identity, strength, quality, and purity [211 CFR 211.160(b)]-specifically in what the Agency described as inadequate testing of incoming USP carbon dioxide and helium gas supplies.

  • establishing and documenting "the accuracy, sensitivity, specificity, and reproducibility" of test methods [21 CFR § 211.165(e)]-specifically failing to validate a gas-chromatographic carbon-dioxide assay.

  • establishing "an adequate quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred, or, if errors have occurred, that they have been fully investigated" [211 CFR § 211.22]. The Warning cited the quality control unit's failure, in the two previous citations, to ensure testing of incoming drug product with a validated test method.