Drug maker Teva Pharmaceutical Industries has received a warning letter from the U.S. Food and Drug Administration (FDA) concerning Current Good Manufacturing Practices (cGMP) at the company’s Gödöllő (Hungary) manufacturing facility.
The FDA letter cites deficiencies in manufacturing operations and laboratory controls, and in the company’s data integrity program, Reuters reports.
The warning letter is the result of an FDA inspection of the Gödöllő facility that took place between January 21 and January 29, 2016.
On May 27, the FDA announced an import alert prohibiting drugs made at the Gödöllő, manufacturing site from entering the U.S, except for the antibiotic Amikacin and the chemotherapy drug Bleomycin. At the time of the alert, a Teva spokesperson said the company was addressing the problems at the facility, Regulatory Affairs Professionals Society (RAPS) reports.
The Gödöllő manufacturing facility opened in 2012. The facility increased Teva’s capacity for producing sterile injectable drugs. The plant has the capacity to make 160 million to 200 million units of injectable medicines each year.
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the Food and Drug Administration. The agency explains:
Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.
The FDA did not offer any additional information about why the import alert was issued, but Teva did receive FDA Form 483. This document usually outlines initial good manufacturing practice violations that precede the issuing of a warning letter, according to RAPS.
A company has 15 working days from receipt of a warning letter to answer in writing about “specific steps” taken to correct the violations and to “ensure that similar violations will not recur.” If the company does not believe the products are in violation of the federal Food, Drug & Cosmetic Act, the company may explain their position to the FDA and provide supporting information. If the company cannot complete corrective action within 15 working days, the response must “state the reason for the delay and the time frame within which the corrections will be implemented.”