FDA Warns Canadian Pharmaceutical Manuf. for CGMP, Labeling Violations
The Food and Drug Administration threatened Canadian manufacturer International Laboratories (Canada) with refusal of its pharmaceutical products and denial of new applications if the company does not correct violations of the Current Good Manufacturing Practice (CGMP) regulations. The FDA warning…
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letter, dated Oct. 23, also said the firm failed to list net contents in U.S. measurements, and listed ingredients considered by FDA to be inactive as active ingredients. FDA said the company has 15 working days from receipt of the letter to notify it of corrective actions.