Mylan gets warning letter from USFDA ...
Home  »  Community News  »  Mylan gets warning l...
Aug
20
ragupathyrenganathan
Mylan gets warning letter from USFDA for lapses at 3 units
Pharma News
0

The US Food & Drug Administration (USFDA) has issued a warning letter to Mylan Laboratories for violation of current good manufacturing practice (CGMP) norms at its three plants in Karnataka. The US regulator said its inspectors found “significant violations” in the three manufacturing facilities in Bengaluru of the company, 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.”

Read more at: http://www.moneycontrol.com/news/business/mylan-gets-warning-letterusfda-for-lapses-at-3-units_2626601.html?utm_source=ref_article



Leave a reply

You must be logged in to post a comment.