USFDA issued Nine 483s to Aurobindo Unit-4
*USFDA issued Nine 483s to Aurobindo Unit-4*
Home Inspections USFDA issued Nine 483s to Aurobindo Unit-4
USFDA issued Nine 483s to Aurobindo Unit-4
March 2, 2018 abhishek kumar killiInspections
USFDA issued Nine 483s to Aurobindo Unit 4 in its latest inspection conducted from Feb 12th to 20th. CNBC-TV18 accesses the form 483 and had briefed 7 out of 9 observations in the microblogging website (Twitter) however, no official information has been received from Aurobindo. The site was inspected by FDA inspector Yasamin Ameri, a chemist / biologist; who is competent in auditing areas like process validation, computer system etc.
*Details of few observations are given below:*
*1)* Buildings used to manufacture and storage of drugs are not free of rodents, birds and insects.
*2)* Employees engaged in manufacturing, processing, packing lack training
*3)* Statistical Quality Control criteria fail to include appropriate acceptance & rejection levels.
*4)* Established lab control mechanisms not followed & documented at the time of performance
*5)* Appropriate controls not exercised over computers or related systems
*6)* Aseptic processing areas deficient of systems used to control aseptic conditions
*7)* Equipment & utensils not cleaned & sanitized at appropriate intervals
The man scope of this audit was confined to review of the batch records and the investigations pertained to potential Class I recalls of its 04 Injectable products. The company has to respond with a detail compliance plan for all the observations issued in not less than 15 days from the last day of inspection.
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