Observing Concerns

FDA issues Form 483 to Aurobindo


The U.S. Food and Drug Administration (FDA) has issued a Form 483 to Aurobindo Pharma Limited in Hyderabad, India, after the generic drug product manufacturing plant neglected to follow sterile procedures, reports I-Pharma Technologist. The FDA conducted an inspection at the plant in December 2018 and found that procedures necessary for the prevention of microbial contamination were not being followed.

The FDA is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374) "Factory Inspection". Form FDA 483 "Inspectional Observations," documents and communicates issues discovered during these inspections. It lists observations made by the FDA representative(s) during the inspection of a facility. Recipients need to respond to the FDA, addressing each item, indicating agreement and either providing a timeline for correction or requesting clarification. Facilities must submit a response within 15 business days, regardless of the number of observations. While a response is not mandatory, a good response can usually help a company avoid receiving a Warning Letter, withholding of product approval or plant shut-down.

While the FDA only made two observations at Aurobindo, the agency’s report is 12 pages long. It cites issues such as “improper set-up of lines for aseptic filling of drug products for the U.S. drug marker and the mishandling of primary packaging components,” according to I-Pharma Technologist. In short, the FDA determined that the company’s response to complaints were not always adequate for products headed for the U.S. market.

In the first observation, the FDA said that active-air sample results from the aseptic filling line were not assured of having adequate air quality throughout the filling procedure. Additionally, the FDA claimed that procedures for air monitoring using the settling plates to monitor the filling area were not at the appropriate working level.

In the second observation, the FDA questioned whether protective apparel was worn to protect drug products from contamination. The agency said that the company operators provided no assurance that the required apparel was being worn in the aseptic production areas, which might lead to contamination.

In March of last year, the same facility received nine observations from the FDA from February 12 to 20. They involved signs of rodents, insects and other vermin, as well as dirt build-ups and uncleaned equipment and utensils causing “potential safety, identity or quality impact on the drug product.” The FDA determined that employees in the manufacturing, processing and packing areas were not getting the training needed for their activities.

Aurobindo also got a Form 483 from the FDA in 2017 asking for changes at two of the company's facilities. At that time the FDA requested a “detailed action plan” for improvements concerning packaging and labelling compliance at one of the units of its Hyderabad plant. This notice was based on a previous field alert report by the agency. The FDA also issued an official warning letter following an earlier import alert on Aurobindo's cephalosporin manufacturing plant; it required detention of products from the facility.



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