Inspection Record

Auro Pharmacies — FDA 483 Findings

US FDAPublished 2024-01-17 8 findingsAseptic processing and sterility assuranceValidation and qualificationOther quality systemEquipment and facilityStability and storageMaterial and supplier control

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, worst-case activities and conditions that provide a challenge to aseptic operations.

2Validation and qualification

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

3Other quality system

You have not established appropriate Beyond Use Dates for your products.

4Equipment and facility

Vermin was observed in an area immediately adjacent to your production area.

5Aseptic processing and sterility assurance

You did not make adequate product evolution and take remedial action where actionable microbial contamination was found to be present in the ISO 5 classified aseptic processing area during aseptic production.

6Stability and storage

The written stability testing program is not followed.

7Aseptic processing and sterility assurance

Personnel conducted aseptic manipulations in an area that blocked the movement of first pass air around an open unit, either before or after it was filled with sterile product.

8Material and supplier control

Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.

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.

Other records for this company

2016-07-19 · US FDA · 9 findings2018-08-28 · US FDA · 9 findings2018-10-24 · US FDA · 11 findings2017-02-08 · US FDA · 14 findings2017-01-20 · US FDA · 14 findings
Auro Pharmacies company profile — full history US FDA documents, 2024 Go to Findings search