FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Mexican Manufacturer Cited For Quality, Conformance Issues

Feb. 2, 2018

The FDA flagged a dozen deficiencies during a September inspection of a Schwabe Mexico facility, including testing and quality problems.

The Xochitepec, Mexico facility failed to assess conformance with its written acceptance specifications. Reviews of batch records and quality test results revealed the firm reported a result without supporting it with an analyzed sample and released products in the U.S. market without proper testing.

The investigator also found that the firm’s component testing procedures were deficient, as they did not include tests for conformity with quality, strength and purity specifications.

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