1Training and personnel
Clothing ofpersonnel engaged in the processing ofdrng products is not appropriate fur the duties they perform.
Inspection Record
Stewart Compounding Pharmacy — FDA 483 Findings
Inspectors Viviana MattaThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
3Equipment and facility
The calibration ofinstruments is not done at suitable interva]s in accordance with an established written program.
4Other quality system
Records are not made concurrently with the perfom1ance ofeach step in the manufacture ofproducts.
5Contamination control
Procedttres designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written, and followed.
6Laboratory and QC controls
Testing and release ofdrug product for distribulion do not include appropriate laboratory determination ofsatisfactory conformance to the identity and strength ofeach active ingredient prior to release.
7Other quality system
The responsibilities and procedures applicable to the quality .controllJilit are not fu11y foJlowed.
8Equipment and facility
Buildings used in the manufacture, processing, packing or hoJdJng ofdrug products are not maintained in a clean and sanitary condition.
9Aseptic processing and sterility assurance
Each batch ofdi-ug product purporting to be sterile is not laboratory tested to determine confotmance to such t·equire:ments.
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.
