Inspection Record

Loop Plaza Pharmacy Company DBA Loop Compounding Pharamacy — FDA 483 Findings

US FDAInspected 2018-09-25Published 2019-04-30 4 findingsValidation and qualificationAseptic processing and sterility assuranceOther quality system

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

Findings

1Validation and qualification

ISO-5 classified areas were not certified under dynamic conditions.

2Aseptic processing and sterility assurance

Non-sterilized or non-depyrogenated tools or temporary containers were used in sterile drug production.

3Aseptic processing and sterility assurance

Media fills were not performed that closely simulate aseptic operations incorporating, as appropriate, worst-case a ctivities and conditions that provide a challenge to aseptic operations.

4Other quality system

The ISO 5 classified is located within a non-classified room (segregated production area).

About this record

Extracted automatically from the document US FDA published on 2019-04-30. 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.

Loop Plaza Pharmacy Company DBA Loop Compounding Pharamacy company profile — full history US FDA documents, 2019 Go to Findings search