Inspection Record

Stonegate Pharmacy LP — FDA 483 Findings

US FDAInspected 2019-08-09Published 2019-10-21 3 findingsTraining and personnelAseptic processing and sterility assuranceOther quality system

Inspectors Jason R CaballeroThe inspectors who signed the published document.Inspector lookup

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

Findings

1Training and personnel

Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.

2Aseptic processing and sterility assurance

Equipment was and Materials or supplies were not disinfected prior to entering the aseptic processing areas.

3Other quality system

Your firm released drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

About this record

Extracted automatically from the document US FDA published on 2019-10-21. 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

2016-03-23 · US FDA · 12 findings2016-03-23 · US FDA · 11 findings2018-07-02 · US FDA · 4 findings
Stonegate Pharmacy LP company profile — full history US FDA documents, 2019 Go to Findings search