Inspection Record

Front Door Pharmacy, LLC — FDA 483 Findings

US FDAInspected 2021-06-07Published 2024-03-22 6 findingsAseptic processing and sterility assuranceOther quality systemValidation and qualificationEquipment and facility

Inspectors Camerson E MooreThe inspectors who signed the published document.Inspector lookup

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

Findings

1Aseptic processing and sterility assurance

Personnel were observed conducting aseptic manipulations or placing equipment/supplies in an area that blocked the movement of first pass air around an open unit, whether before or after it is filled with sterile product.

2Other quality system

Camerson E Moore Investigator Signed By: Camerson E.

3Aseptic processing and sterility assurance

The use of sporicidal agents in the cleanrooms and ISO 5 classified aseptic processing area was inadequate.

4Validation and qualification

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

5Equipment and facility

Your facility design allowed the influx of poor-quality air into a higher classified area.

6Aseptic processing and sterility assurance

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

About this record

Extracted automatically from the document US FDA published on 2024-03-22. 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.

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