Inspection Record

Pavilion Compounding Pharmacy — FDA 483 Findings

US FDAInspected 2019-02-08Published 2019-08-09 4 findingsOther quality systemContamination controlDocumentation and records

Inspectors Jennifer L HuntingtonThe inspectors who signed the published document.Inspector lookup

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

Findings

1Other quality system

Procedures designed to prevent insanitaiy conditions are not established or followed.

2Other quality system

Unsealed, loose ceiling tiles were observed in your cleamnroom.

3Contamination control

You produced hazardous drugs without providing adequate containment, segregation and cleaning of personnel to prevent cross-contamination.

4Documentation and records

Batch production and control records do not include complete information relating to the production and control of each batch.

About this record

Extracted automatically from the document US FDA published on 2019-08-09. 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.

Pavilion Compounding Pharmacy company profile — full history US FDA documents, 2019 Go to Findings search