Inspection Record

Lonza Houston, Inc — FDA 483 Findings

US FDAInspected 2020-12-10Published 2021-01-14 4 findingsContamination controlMaterial and supplier controlOther quality system

Inspectors Steven E BowenThe inspectors who signed the published document.Inspector lookup

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

Findings

1Contamination control

Microbial contamination controls are not adequate.

2Material and supplier control

The identity of each incoming batch of certain raw materials is not verified.

3Other quality system

Written procedures are not always followed.

4Material and supplier control

Physical and electronic control of material storage areas is not adequate.

About this record

Extracted automatically from the document US FDA published on 2021-01-14. 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.

Lonza Houston, Inc company profile — full history US FDA documents, 2021 Go to Findings search