The US Food and Drug Administration(USFDA) has issued Form 483 with 9 observations to Aurobindo PharmaLimited's unit 4 in Hyderabad, citing serious deficiencies in maintaining the manufacturing quality standards. The FDA representatives had inspected the facility between February 12-20, 2018.
Located in Pashamailaram industrial estate on the city outskirts, Unit-4 is a dedicated manufacturing facilityfor generic sterile injectables ( lyophilized and powder injections, prefilled syringes), opthalmics and low volume parenterals.
According to the Form 483, a copy of which was reviewed by this reporter, the inspection team has noticed poor maintenance of equipment and premises among other quality issues at the site.
The FDA representative also noted that despite alerting the management regarding certain black stains on a filling machine, no action was taken to remove the dirt, which could potentially impact the quality of the drug product.
"Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product," the inspection team members noted while painting a poor state of affairs at the plant.
The company is yet to respond to these observations.
A Form 483 is issued to the management at the conclusion of an inspection in case an investigator observed any conditions that in their judgement constitute violations of Food, Drug and Cosmetic Act among other related laws of the US Government.
These inspectional observations are not the agency's final conclusions on any compliance issue in question as the company management will be allowed to respond to these observations within 15 working days to express objections, if any, to these observations and, or propose a corrective action plan. The matter can be escalated to a much serious import alert on the manufacturing facilityif these observations were not being addressed to the satisfaction of the US drug regulator.
While most of the observations recorded during the inspection of Pashamailaram plantwere related to the lack of proper practices in place to ensure the quality and purity of the drug productbeing produced at the site, the inspection team has also pointed out at the lack of proper training of the employees engaged in the manufacture, processing, packaging and holding of a drug product.
During the inspection, a vial washer failed to demonstrate if vial washer was able to remove ' bioburden' from ml glass vials that are used for filing, according to one of these observations.
The investigators also noted that the buildings used in the manufacture, processing, packaging or holding of drug productswere not free of infestation by rodents, birds, insects, and other vermin.
Besides this, the investigators also recorded certain serious deviations in documentation of the processes. In one of their observations the FDA investigators noted that the established laboratory control mechanisms were not followed and documented at the time of performance. They have also noted that appropriate controls were not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorised personnel.
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发表于 2018-3-6 13:14:23
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