Inspection Record

South Berwick Pharmacy Seacoast Compounding, Inc. — FDA 483 Findings

US FDAInspected 2022-09-30Published 2022-12-20 4 findingsContamination controlMaterial and supplier controlEquipment and facility

Inspectors Daniel L Zheng · Erik W KoesterThe 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

Non-microbial contamination was observed in your production area.

2Contamination control

You produced hazardous drug; without providing adequate containment, segregation, cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.

3Material and supplier control

You used a non-pharmaceutical grade component in the formulation of a drug product.

4Equipment and facility

Vermin was observed in your production area.

About this record

Extracted automatically from the document US FDA published on 2022-12-20. 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.

South Berwick Pharmacy Seacoast Compounding, Inc. company profile — full history US FDA documents, 2022 Go to Findings search