Inspection Record

PharmScript LLC — FDA 483 Findings

US FDAInspected 2016-10-24Published 2019-10-23 5 findingsAseptic processing and sterility assuranceValidation and qualificationTraining and personnelEquipment and facilityOther quality system

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

Findings

1Aseptic processing and sterility assurance

Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, w orst-case activities and conditions that provide a challenge to aseptic operations.

2Validation and qualification

The ISO 5 redacted (b)(4) was not certified under dynamic conditions.

3Training and personnel

Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.

4Equipment and facility

4) 'during I A HEPA filter in the redacted (b)(4) of the ISO 5 redacted (b)(4) failed airflow testing on redacted (b)(4) during certification.

5Other quality system

Cleaning and disinfecting of the ISO 5 redacted (b)(4) is inadequate.

About this record

Extracted automatically from the document US FDA published on 2019-10-23. 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.

Other records for this company

2018-08-07 · US FDA · 4 findings
PharmScript LLC company profile — full history US FDA documents, 2019 Go to Findings search