“At the end of the inspections, we have been issued a Form 483 with four observations for each facility. We believe that these observations are related to procedural improvements and none of the observations are related to data integrity,” the company said in a BSE filing.
Aurobindo Pharma on Wednsday said the US Food and Drug Administration (USFDA) has issued four observations each for its two manufacturing units in Hyderabad after inspecting the sites last month. The USFDA inspected active pharmaceutical ingredients (API) manufacturing facility (Unit V) at Pashamylaram and Unit VIII at Gaddapotharam in Hyderabad between October 21 and 28.
“At the end of the inspections, we have been issued a Form 483 with four observations for each facility. We believe that these observations are related to procedural improvements and none of the observations are related to data integrity,” the company said in a BSE filing. The company will be responding to the USFDA as per the prescribed time lines, it said. The inspection of formulation manufacturing facility (Unit IV) at Pashamylaram is underway, it added. It further said that USFDA audit is an activity under the normal course of business in the pharmaceutical industry.
Incidentally, last month, the company had received seven observations from the USFDA for its Unit-VII formulation plant in Telangana. The company clarified that none of the seven observations from the US health regulator for its unit was linked to data integrity. However, the USFDA had said: “The responsibilities and procedures applicable to the quality control unit are not fully followed. Several lists of documents requested were either provided as incomplete, inaccurate and/or explained with potentially misleading statements throughout the inspection.”
In another observation, the USFDA team said: “Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.”
The regulator had earlier said that there were no written procedures for production and process controls to assure quality, and that the responsibilities and procedures applicable to quality control were not fully followed. Besides, it was not satisfied with the cleanliness of the equipment and utensils used to manufacture medicines.