Inspection Record

Algunas Inc. dba Woodland Hills Compounding Pharmacy — FDA 483 Findings

US FDAInspected 2016-05-19Published 2024-01-17 3 findingsEquipment and facilityDeviation, CAPA, and investigationComplaint and recall handling

Inspectors Roger F ZabinskiThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Equipment and facility

Routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance.

2Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

3Complaint and recall handling

Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.

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.

Other records for this company

2016-05-19 · US FDA · 3 findings
Algunas Inc. dba Woodland Hills Compounding Pharmacy findings history — including this company's other documents US FDA documents, 2024 Go to Findings search