Bolus of FDA Warning Letters to Foreign Manufacturers Spans Regions and Product Types

During a two-week period in late February and early March, FDA’s drug compliance office issued a bolus of six warning letters to foreign manufacturers that span across regions and product types, including two each on active pharmaceutical ingredients (APIs), over-the-counter (OTC) solutions and injectables.

The API manufacturers receiving letters during the two-week timeframe were Farma Quimia in Cuautitlan Izcalli, Mexico and Nobilus Ent in Kutno, Poland.  The OTC solution manufacturers were Pax-All in Mississauga, Ontario, Canada, and Laboratorios Jaloma in Guadalajara, Mexico.  The two injectable producers were Wintac in Bangalore, India and Gulf Pharmaceuticals in Ras al Khaimah, United Arab Emirates (UAE).

Four of the firms receiving the letters – Nobilus Ent, Laboratorios Jaloma, Pax-All and Gulf – had already been placed under an import alert by FDA based on the significance of the inspection findings.

An import alert means that no products produced at the sites are allowed admission into the US.  The import restriction will continue to be in force at least until the issues raised in the warning letters are resolved.  FDA cautioned the remaining two companies – Farma Quimia and Wintac – that they may be facing an import alert as well if the issues are not resolved.

At the same time the six letters were posted, FDA also released a warning letter issued in October addressing sterile product manufacturing at SmithKline Beecham’s facility in Worthing, West Sussex, UK.

A warning letter followed to a third Mexican company in late March.  The recipient was an API contract testing lab in Cuautitlan, Izcalli, run by the National Autonomous University of Mexico (UNAM).

On the domestic API manufacturing front, Bakersfield, California-based Nusil was issued a warning letter that went out during the same time frame as the foreign grouping.

Also issued in early March was a warning letter to Warner Chilcott addressing production of an oral solid contraceptive at its plant in Fajardo, Puerto Rico (see IPQ “In the News” May 2, 2012).

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