FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Mexican Manufacturer Cited for Poor Recordkeeping, Investigations

Aug. 28, 2018
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The FDA rapped finished drugmaker Higiene + Salud for shoddy recordkeeping and deficient investigations after a November inspection of the company’s Toluca, Mexico facility.

The firm failed to identify some finished products with approval status labels, according to the Form 483. One lot of 87 boxes lacked a status label and one container of solution was not identified with a product code, lot number, quantity, expiration date or status.

The investigator also found the company had no documentation that it trained its employees and lacked written training requirements for specific tasks.

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