Inspection Record

Downing Labs, LLC — FDA 483 Findings

US FDAInspected 2018-11-19Published 2019-04-30 4 findingsStability and storageAseptic processing and sterility assuranceEquipment and facility

Inspectors Scott T Ballard · 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

1Stability and storage

Results of stability testing are not used in determining appropriate storage conditions.

2Aseptic processing and sterility assurance

Equipment was not disinfected p1ior to entering the aseptic processing areas.

3Equipment and facility

Your facility was designed and/or operated in a way that permits poor flow of materials.

4Aseptic processing and sterility assurance

The JSO 5 classified aseptic processing areas had difficult to clean equipment or surface.

About this record

Extracted automatically from the document US FDA published on 2019-04-30. 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

2015-10-23 · US FDA · 10 findings
Downing Labs, LLC company profile — full history US FDA documents, 2019 Go to Findings search