Inspection Record

Drugs are Us, Inc. (dba Hopewell Pharmacy) — FDA 483 Findings

US FDAInspected 2015-07-10Published 2024-01-17 3 findingsStability and storageTraining and personnelAseptic processing and sterility assurance

Inspectors Nicholas A. Violand · Karen E. D' OrazioThe 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

An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.

2Training and personnel

Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.

3Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

About this record

Extracted automatically from the document US FDA published on 2024-01-17. 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.

Drugs are Us, Inc. (dba Hopewell Pharmacy) company profile — full history US FDA documents, 2024 Go to Findings search