Inspection Record

Dignity Health- Northridge Hospital Medical Center — FDA 483 Findings

US FDAInspected 2016-03-24Published 2024-01-17 8 findingsTraining and personnelAseptic processing and sterility assuranceEquipment and facilityOther quality systemStability and storage

Inspectors Uttaniti LimchumroonThe inspectors who signed the published document.Inspector lookup

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

Findings

1Training and personnel

Clothing of personnel engaged in the manufacturing, processing, packing and ho lding ofdrug products is not appropriate for the duties they perform.

2Aseptic processing and sterility assurance

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

3Equipment and facility

Buildings used in the manufacture, processing, packing or holding ofdrug products are not maintained in a clean and sanitary condition.

4Aseptic processing and sterility assurance

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

5Other quality system

There is a fa ilure to thoroughly review whether or not the batch has been already distributed.

6Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.

7Aseptic processing and sterility assurance

Aseptic processing areas are deficient in that ceilings are not smooth and/or hard surfaces that are easily cleanable.

8Stability and storage

There is no written testing program designed to assess the stability characteristics of drug products.

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.

Dignity Health- Northridge Hospital Medical Center company profile — full history US FDA documents, 2024 Go to Findings search