The Food and Drug Administration (FDA) has ordered the recall of all drug products manufactured since last year by three pharmaceutical firms from the market due to “critical and major findings” of noncompliance with international good manufacturing practice standard for medicines.
In three separate advisories, the FDA also ordered Allied Pharmaceutical Laboratories Inc., Doctors Pharmaceuticals Inc. and Morishita-Seggs Pharmaceuticals Inc. to stop their manufacturing operations.
Affected by the recall were medicines manufactured from January 2014 up to present by Allied Pharmaceutical and Morishita-Seggs Pharmaceuticals and those produced since March last year by Doctors Pharmaceuticals.
“Critical and major findings of nonconformance to Pharmaceutical Inspectorate Cooperation Scheme-Good Manufacturing Practice (PIC/S-GMP) were noted upon inspection of the said manufacturing [facilities], which indicates that there is no assurance that the manufactured products are of good quality,” stated the FDA.
According to its website, PIC/S is an international instrument between countries and pharmaceutical inspection authorities, which provide an active and constructive cooperation in the field of GMP.
GMP are the practices necessary to conform to guidelines recommended by regulating and licensing bodies for the manufacture and sale of food, drug and pharmaceutical products to ensure that these products are safe for the public and are of high quality. Jocelyn R. Uy