1Quality unit oversight
The quality control unit lacks responsibility to approve all procedures or specifications impacting the quality of drug products.
Inspection Record
Intas Pharmaceuticals — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by birds.
3Laboratory and QC controls
Laboratory Controls do not include the establishment of scientifically sound and appropriate standards, sampling plans and test procedures designed to assure that drug products conform to appropriate standards of identity strength, quality and purity.
4Contamination control
Cell banks were not maintained under appropriate storage monitoring conditions designed to maintain viability and prevent contamination and records ofthe use of the vials from the cell banks and storage conditions were not maintained.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
6Equipment and facility
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
7Training and personnel
Employees are not given training in the particular operations they perform’as part of their function.
About this record
Extracted automatically from the document US FDA published on 2017-07-19. 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.
