USFDA pulls up Mylan for manufacturing violations at Andhra plant
New Delhi: American health regulator USFDA has pulled up Mylan Laboratories for violation of good manufacturing norms, including lapses in handling raw materials and issues related with cleaning of equipment, at its Andhra Pradesh-based manufacturing facility. In a warning letter issued to the company's CEO Heather Bresch, the US Food and Drug Administration (USFDA) said inspectors during May 27 to June 5, this year found significant deviations from standard manufacturing practices at the company's Unit 8 in G Chodavaram village in Vizianagaram.
"This warning letter summarises significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API)," the USFDA said.
The significant violations included failure to have adequate written procedures for the receipt, identification, testing and handling of raw materials.
"Your procedures for receiving, identifying, testing, and handling raw materials were inadequate to ensure suitability of materials used in manufacturing, including preventing contamination and cross-contamination with nitrosamine impurities such as N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA)," the US health regulator said.
The company had not anticipated the presence of NDMA or NDEA impurities based on its assessment of the API manufacturing process, it added.
It also pointed out to the company's failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the API beyond the official or other established specifications.
"There is no assurance that your cleaning methods are adequate to clean and prevent contamination or carry-over of drugs manufactured on non-dedicated equipment," USFDA said.
The inspectors observed that non-dedicated equipment were labelled as clean, however, when the interior surfaces of the chutes were wiped with lint-free clothes stains were observed, it added.
"Based upon the nature of the deviations we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations to assist your firm in meeting current good manufacturing practices (CGMP) requirements," USFDA said.
Until all corrections have been completed and FDA has confirmed corrections of the violations and the firm's compliance with CGMP, FDA may withhold approval of any new applications or supplements, it added.
In addition, the company's failure to correct these violations may result in FDA continuing to refuse admission of articles manufactured at the plant into the US, the regulator said.
The FDA issued the letter on November 5, and has given the company 15 days to respond.
"This warning letter summarises significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API)," the USFDA said.
The significant violations included failure to have adequate written procedures for the receipt, identification, testing and handling of raw materials.
"Your procedures for receiving, identifying, testing, and handling raw materials were inadequate to ensure suitability of materials used in manufacturing, including preventing contamination and cross-contamination with nitrosamine impurities such as N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA)," the US health regulator said.
The company had not anticipated the presence of NDMA or NDEA impurities based on its assessment of the API manufacturing process, it added.
It also pointed out to the company's failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the API beyond the official or other established specifications.
"There is no assurance that your cleaning methods are adequate to clean and prevent contamination or carry-over of drugs manufactured on non-dedicated equipment," USFDA said.
The inspectors observed that non-dedicated equipment were labelled as clean, however, when the interior surfaces of the chutes were wiped with lint-free clothes stains were observed, it added.
"Based upon the nature of the deviations we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations to assist your firm in meeting current good manufacturing practices (CGMP) requirements," USFDA said.
Until all corrections have been completed and FDA has confirmed corrections of the violations and the firm's compliance with CGMP, FDA may withhold approval of any new applications or supplements, it added.
In addition, the company's failure to correct these violations may result in FDA continuing to refuse admission of articles manufactured at the plant into the US, the regulator said.
The FDA issued the letter on November 5, and has given the company 15 days to respond.
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