Inspection Record

Brookfield Medical Surgical Supplies — FDA 483 Findings

US FDAInspected 2024-05-10Published 2024-06-28 3 findingsProcess validationAseptic processing and sterility assuranceLabeling and packaging

Inspectors Jonathan G Matrisciano · Ogechi C Nna · Armen H YoussoufianThe 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.

2Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.

3Labeling and packaging

The container of your outsourcing facility's drug products does not include information required by section 503B(a)(I0)(B) of the Federal Food, Dmg, and Cosmetic Act (FD&C Act).

About this record

Extracted automatically from the document US FDA published on 2024-06-28. 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.

Brookfield Medical Surgical Supplies company profile — full history US FDA documents, 2024 Go to Findings search