The US regulator said its inspectors found significant violations in the three manufacturing facilities in Bengaluru, which is an arm of US-based Mylan Inc. Of the three units, two plants belonged to Agila Specialties, which Mylan had acquired from Strides Arcolab in 2013-end. The other unit is owned by Mylan Laboratories.
"At all three sites, we identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals," USFDA said.
The methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP, the US health regulator said.
On the Mylan's Bengaluru facility, the USFDA said, "The significant violations included failure of the company to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilisation processes."
Besides, non-integral gloves were used in suites for conducting aseptic processing operations, it added. Deficiencies in your operators' practices indicate that your manufacturing personnel monitoring program is deficient, USFDA said.
USFDA also raised concern about the company's failure to review the results of microbial tests to identify possible trending problems in environmental control in aseptic processing areas.
"Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labelling, and drug products conform to appropriate standards of identity, strength, quality, and purity," it further noted.
Query sent to Mylan Laboratories remained unanswered. Commenting on lapses at Agila Specialties' two units, USFDA noted, "During our review of several media fill batch records (MFBR), we documented that integral vials identified as 'jam rejects' or 'other rejects' were rejected without assignable causes, and not incubated."
Besides, the company 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, it added.
"These items found at three different sites, together with other deficiencies found by our investigators, raise questions about the ability of your current corporate quality system to achieve overall compliance with CGMP. Furthermore, several violations are recurrent and long-standing," it said.
Until the company completes all corrections and USFDA confirms corrections and compliance with CGMP, FDA may withhold approval of any new applications or supplements listing Mylan as a drug product manufacturer, USFDA noted.
Later in the day, Mylan said in a statement that the USFDA action has no material impact on the company's business or its previously announced full year earnings guidance.
"Since Mylan acquired the Agila injectables businesses in December 2013 to create a leading global injectables platform, we have been taking extensive action to integrate the Agila business into Mylan's One Quality Standard, and to ensure our leading position as a high quality, reliable source of injectables for the long term," Mylan CEO Heather Bresch said.
As part of this ongoing process, the company has a deep and unwavering commitment to quality everywhere it operates, he added.
"We have been and will continue to work diligently to address all of the FDA's observations and have made important progress," Bresch added.
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