1Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Inspection Record
LEESAR, INC — FDA 483 Findings
Inspectors Jennifer Lalama · 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
2Documentation and records
The master production and control records are deficient in that they do not include a statement of theoretical yield and yield percentages.
3Labeling and packaging
The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(IO)(A).
4Material and supplier control
Written procedures are not established that describe the tests to be conducted on appropriate samples of in-process materials of each batch.
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.
About this record
Extracted automatically from the document US FDA published on 2022-03-16. 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.
