1Equipment and facility
Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.
Inspection Record
Aurobindo Pharma Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Established laboratory control mechanisms are not followed and documented at the time ofperformance.
3Equipment and facility
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.
4Laboratory and QC controls
The statistical quality control criteria fail to include appropriate acceptance levels and rejection levels.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
6Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
7Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
8Training and personnel
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.
About this record
Extracted automatically from the document US FDA published on 2018-03-06. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
