1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
PharMEDium Services, LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Samples taken of drug products for determination of conformance to written specifications are not representative.
3Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality, and purity.
4Labeling and packaging
Packaging and labeling records do not include a specimen of all labels used.
5Other quality system
Input to and output from the computer, related systems of formulas, or records or data are not checked for accuracy.
6Equipment and facility
The calibration of instruments is not done at suitable intervals in accordance with an established written program.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
