Teva's troubled Godollo plant earns firm US FDA warning letter

By Gareth Macdonald contact

- Last updated on GMT


Related tags: Pharmaceutical drug

The US FDA has warned Teva Pharmaceutical Industries about its facility in Godollo, Hungary over ongoing concerns about manufacturing operations.

The Israeli drug manufacturer announced the warning letter in a US Securities and Exchange Commission (SEC) last week​, explaining that the agency had raised concerns about production and laboratory activities at the site.

The letter cites deficiencies in manufacturing operations and laboratory controls, and in the Company’s data integrity program. Teva has undertaken corrective actions to address both the specific concerns raised by investigators as well as the underlying causes of those concerns. Communication with the FDA is ongoing​.”

Teva said it will respond to the Warning Letter​ on November 4.


The Godollo facility has ceased production of all but two of the 200 drugs previously made at the site in January following a US Food and Drug Administration (FDA) inspection that uncovered a number of problems.

On May 27 the US FDA issued an import alert​ on almost all sterile injectable drugs made at the facility citing unspecified good manufacturing practices (GMP) problems.

Until August Teva had been permitted to ship two drugs made at the facility – the antibiotic Amikacin sulfate and the cancer medication bleomycin – to the US.

Previously both products were identified as being in short supply in the US. However, on August 9​, Amikacin was removed from the list prompting Teva to withdraw​ the product.

In September​ the firm told us it was “months away​” from restarting production at the site.

Related topics: Markets & Regulations, QA/QC, Regulations

Related news

Show more

Related products

Transforming Clinical Development

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

Follow us


View more