1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
Inspection Record
PQ Pharmacy LLC — FDA 483 Findings
Inspectors Joanne E King · Kayla V SpragueThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
3Laboratory and QC controls
The written stability program for drug products does not include reliable test methods.
4Quality unit oversight
The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
5Regulatory reporting and change control
Your outsourcing facility did not submit a report to FDA identifying the drugs compounded during the previous six month period.
6Stability and storage
An adequate number of batches of each drug product are not tested nor are records of such data maintained to determine an appropriate expiration date.
About this record
Extracted automatically from the document US FDA published on 2023-01-30. 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.
