1Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Inspection Record
Exela Pharma Sciences LLC — FDA 483 Findings
Inspectors Logan Williams · Santos Camara · Megan Ziegler and 1 moreThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Laboratory records do not include complete records of any testing and standardization of laboratory standard solutions.
3Material and supplier control
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected components, drug product containers and closures before disposition.
4Deviation, CAPA, and investigation
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
5Equipment and facility
The calibration of instruments and recording devices is not done at suitable intervals in accordance with an established written program.
6Computer 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.
7Laboratory and QC controls
Established laboratory control mechanisms are not followed and documented at the time of performance.
8Training and personnel
Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
9Process validation
Written production and process control procedures are not followed in the execution of production and process control functions.
10Quality unit oversight
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of components, drug product containers, and closures pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging.
11Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
12Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
13Laboratory and QC controls
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy and completeness.
About this record
Extracted automatically from the document US FDA published on 2025-02-14. 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.
