FDA warning letter to German drugmaker for Baddi plant
New Delhi: US health regulator USFDA has issued a warning letter to German drug firm Fresenius Kabi AG for lapses at its drug manufacturing facility at Baddi in Himachal Pradesh.
In a letter to the company's CEO Mats Henriksson summarising violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, United States Food and Drug Administration (USFDA) said it had conducted inspection of the Baddi facility from April 6 to 14, 2017.
"Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed," the health regulator said.
While saying that it had reviewed company's May 10, 2017, response in detail and acknowledges receipt of its subsequent correspondence, USFDA asked the drug firm to provide plans and procedures to ensure that future sterility failure investigations included a more thorough review of long-term trends.
The regulator also asked Fresenius Kabi AG to ensure sufficient investigation of potential vulnerabilities in the manufacturing operation and potential correlations with past incidents.
The letter also said that in an inspection from May 14 to 22, 2015, FDA had cited a similar CGMP observation in which the company invalidated sterility test failures without adequately investigating the root causes, and failed to take timely and appropriate corrective actions.
"Although you proposed remediations in your responses following the 2015 inspection, and discussed these plans during a 2016 regulatory meeting with the Agency, our current inspection found that your facility's oversight and control over the manufacture of drugs remains deficient," it added.
Recommending engaging of CGMP Consultant, USFDA said based upon the nature of the violations it strongly recommended engaging a consultant to assist the company in meeting CGMP requirements.
The regulator said until the company corrects all violations completely and "we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer."
Failure to correct these violations may also result in FDA refusing admission of articles manufactured at Fresenius Kabi Oncology at Baddi in the United States, USFDA said.