1Aseptic processing and sterility assurance
Procedw-es designed to prevent microbiological contamination ofdrug products purporting to be sterile are not followed.
Inspection Record
Leiter’s Compounding — FDA 483 Findings
Inspectors Anh Lac · Alicia K. MckinseyThe 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 quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality, and purity ofdrug products.
3Labeling and packaging
The labels ofyom firm's drug products observed by FDA do not conta.in information required by section 503B(a)(l0) ofthe Act.
4Material and supplier control
There is a fuilure to thorougbJy review the failure of a batch or any of its components to meet any ofits specifications whether or not the batch has been already distributed.
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.
