Regulatory Focus™ > News Articles > 2019 > 7 > FDA Sends Warning Letters to Aurobindo, API Repackers

FDA Sends Warning Letters to Aurobindo, API Repackers

Posted 03 July 2019 | By Michael Mezher 

FDA Sends Warning Letters to Aurobindo, API Repackers

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Indian drugmaker Aurobindo Pharma last month and issued a statement drawing attention to three recent warning letters sent to active pharmaceutical ingredient (API) repackers.
 
Aurobindo
 
In its warning letter to Aurobindo, FDA cites the company for good manufacturing practice (GMP) violations at one of the company’s facilities in Srikakulam District, Andhra Pradesh following a six-day inspection in February.
 
While all mention of specific products, APIs and impurities have been redacted from the warning letter, it appears that the warning letter is related to nitrosamine impurities in angiotensin II receptor blockers (ARBs) that have prompted FDA to recall hundreds of lots of the drugs from multiple manufacturers.
 
Shortly after the inspection, Aurobindo expanded its voluntary recall of ARB drugs to include 38 lots of Valsartan tablets due to the presence of an N-nitrosodiethylamine (NDEA) impurity.
 
The warning letter also cites testing performed by the European Directorate for the Quality of Medicines (EDQM) that occurred prior to January 2019, referencing an impurity found in one of the company’s products. In October 2018, EDQM suspended Aurobindo’s certificate of suitability (CEP) for irbesartan after identifying NDEA impurities in the drugs.
 
In the warning letter, FDA says Aurobindo failed to adequately investigate the root cause of the impurities as its initial assessment “did not include an evaluation for the potential for key starting materials (KSM), other raw materials, and solvents to result in the presence of” two impurities that have been redacted from the letter.
 
FDA also says it observed rust on the surface of equipment used to manufacture one of the company’s APIs.
 
Additionally, FDA says the company failed to submit a required supplemental report detailing specification changes for one of its drug master files.
 
Repackers
 
In a statement issued Tuesday, FDA announced it has sent warning letters to three API repackers, B&B Pharmaceuticals, Asclemed USA and Spectrum Laboratory Products for violating GMP requirements.
 
“The supply chain issues we have found in the API repacking industry broadly pose a real threat to the public health and we’re calling on them to address these issues as quickly as possible,” said Center for Drug Evaluation and Research Director Janet Woodcock.
 
Woodcock also urged repackers to “follow all quality standards pertaining to them – including clearly identifying the original manufacturer of the drugs.”
 
FDA noted that it has sent warning letters to five other companies for repackaging issues within the last year and has issued alerts over safety concerns stemming from repackaged porcine thyroid API and baclofen API.
 
Aurobindo Warning Letter, Repackers Statement

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe