Inspection Record

New Era Pharmacy, LLC — FDA 483 Findings

US FDAInspected 2019-11-27Published 2020-01-27 4 findingsContamination controlMaterial and supplier controlAseptic processing and sterility assuranceValidation and qualification

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

Findings

1Contamination control

Protective apparel is not worn as necessary to protect drug products from contamination.

2Material and supplier control

Non-pharmaceutical grade components are used in the formulation of non-sterile drug products.

3Aseptic 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.

4Validation and qualification

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

About this record

Extracted automatically from the document US FDA published on 2020-01-27. 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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