Inspection Record

One Way Drug, LLC dba Partell Specialty Pharmacy — FDA 483 Findings

US FDAInspected 2017-10-02Published 2024-01-17 3 findingsEquipment and facilityOther quality systemLaboratory and QC controls

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

Findings

1Equipment and facility

Written procedures are not established for the cleaning and maintenance ofe quipment, including utensils, used in the manufacture, processing, packing or holding of a drug product Specifically, Your firm has not established written and approved procedures for the cleaning of equipment and utensils used in the preparation of drug products.

2Other quality system

Drug products failing to meet established specifications are not rejected.

3Laboratory and QC controls

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.

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

2015-07-10 · US FDA · 7 findings
One Way Drug, LLC dba Partell Specialty Pharmacy findings history — including this company's other documents US FDA documents, 2024 Go to Findings search