Inspection Record

Nubratori, Inc. — FDA 483 Findings

US FDAInspected 2025-12-11Published 2026-01-22 3 findingsProcess validationEquipment and facilityAseptic processing and sterility assurance

Inspectors Lucila B NwatuThe inspectors who signed the published document.Inspector lookup

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

Findings

1Process validation

Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

2Equipment and facility

Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

3Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and written.

About this record

Extracted automatically from the document US FDA published on 2026-01-22. 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.

Other records for this company

2024-07-26 · US FDA · 6 findings
Nubratori, Inc. findings history — including this company's other documents US FDA documents, 2026 Go to Findings search