Inspection Record

BioScrip Pharmacy (NY), Inc. — FDA 483 Findings

US FDAInspected 2015-12-11Published 2024-01-17 9 findingsContamination controlAseptic processing and sterility assuranceStability and storageTraining and personnelLaboratory and QC controls

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

Findings

1Contamination control

The separate or defined areas necessary to prevent contamination or mix-ups are deficient.

2Aseptic processing and sterility assurance

Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.

3Stability and storage

There shall be a written testing program designed to assess the stability characteristics of drug products.

4Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

5Aseptic processing and sterility assurance

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

6Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.

7Training and personnel

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

8Laboratory and QC controls

For each batch of drug product, there shall be appropriate laboratory determination of satisfactory conformance to fin al specifications for the drug product.

9Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.

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.

BioScrip Pharmacy (NY), Inc. company profile — full history US FDA documents, 2024 Go to Findings search