Inspection Record

Farmakeio Outsourcing LLC — FDA 483 Findings

US FDAInspected 2019-10-30Published 2020-06-18 3 findingsLabeling and packagingOther quality systemAseptic processing and sterility assurance

Inspectors Francis A GuidryThe inspectors who signed the published document.Inspector lookup

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

Findings

1Labeling and packaging

The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(l O)(A).

2Other quality system

You compound drugs that are essentially a copy of one or more approved drugs within the meaning of sections 503B(a)(S) and 503B(d)(2).

3Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

About this record

Extracted automatically from the document US FDA published on 2020-06-18. 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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