Inspection Record

QuVa Pharma, Inc. — FDA 483 Findings

US FDAInspected 2022-06-16Published 2022-12-07 4 findingsLabeling and packagingOther quality systemAseptic processing and sterility assuranceDocumentation and records

Inspectors Camerson E Moore · Damaris Y HernandezThe 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)(I0)(A).

2Other quality system

Input to and output from the computer and records or data are not checked for accuracy.

3Aseptic processing and sterility assurance

Aseptic processing areas are deficient in that floors are not smooth and/or hard surfaces that are easily cleanable.

4Documentation and records

The master production and control records are deficient in that they do not include complete manufacturing and instructions.

About this record

Extracted automatically from the document US FDA published on 2022-12-07. 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

2026-05-04 · US FDA · 3 findings2025-03-04 · US FDA · 5 findings2024-10-28 · US FDA · 4 findings2016-03-12 · US FDA · 4 findings2016-03-12 · US FDA · 5 findings2018-05-30 · US FDA · 4 findings
QuVa Pharma, Inc. findings history — including this company's other documents US FDA documents, 2022 Go to Findings search