Neuland Laboratories’ manufacturing facility at Bonthapally, Hyderabad has been audited by the United States Food and Drug Administration (USFDA) from April 3-7, 2017. At the end of the inspection, there were 2 observations given under form 483.
The two observations relates to procedures followed for the annual quality standards record evaluation and cleaning and maintenance of equipment at appropriate intervals during manufacturing campaign. The company has already initiated corrective and preventive actions for the observations and is confident of satisfying the USFDA within the stipulated time.
Neuland Laboratories manufactures active pharmaceutical ingredients for global pharmaceutical companies and provides end-to-end solutions for the pharmaceutical industry for chemistry-related services. It supplies to pharmaceutical companies across India, Europe and North America amongst others with a presence in over 85 countries. The company has two manufacturing facilities in Hyderabad, Telangana.