Pharmaceutical manufacturer Zydus Cadila said that the United States Food and Drug Administration (USFDA) issued 11 observations after inspections at two of the manufacturing facilities of Nesher Pharmaceuticals, a subsidiary of Zydus’ US arm. Both the facilities are located at St Louis, United States.
issuing of observations indicate that the inspectors did not find everything up to their satisfaction and want the company to make amendments to its procedures and process at the facility.
Zydus said that the inspection concluded with 3 observations for one facility and 8 observations, including a recommendation for Voluntary Action Indicated (VAI).
According to USFDA, Voluntary Action Indicated means that certain objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
Zydus said that it was a product-specific pre-approval inspection. It added that there was no Data Integrity (DI) related observations.
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 carried out from May 13 to May 31.
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.
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.