Pharmaceutical manufacturer Zydus Cadila said that the United States Food and Drug Administration has issued 14 observations after an inspection at its manufacturing facility at Moraiya, Ahmedabad.
Observations indicate that the inspectors did not find everything up to order, and want the company to make amendments to its procedures and process at the facility.
Moraiya is the drugmaker’s largest facility that makes key anti-inflammatory drugs like Lialda and Asacol HD for the US market.
Zydus said that the latest observations did not contain any repeat observations or Data Integrity (DI) related ones
According to USFDA, Data Integrity related observations refer to the completeness, consistency, and accuracy of data, which should be attributable, legible, original, and accurate.
Zydus said that it is confident of addressing the observations and responding to USFDA at the earliest to get the inspection report.
The inspection was conducted from April 22 to May 3.
Normally, observations are given in a ‘Form 483’. In a Form 483, the FDA typically outlines conditions or practices at a drug-making unit that may cause the products made there to be in violation of the US agency’s standard production requirements.
Last year, the food and drug regulator had completed an inspection at the Moraiya facility in February 2018 with no observation.
Headquartered in Ahmedabad, Zydus Cadila has manufacturing sites and research facilities across Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim and in the United States and Brazil.