Inspection Record

OurPharma LLC — FDA 483 Findings

US FDAInspected 2024-09-27Published 2025-02-07 5 findingsRegulatory reporting and change controlAseptic processing and sterility assuranceLabeling and packagingProcess validation

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Findings

1Regulatory reporting and change control

Your outsourcing facility has not submitted a report to FDA identifying a product compounded during the previous six months as required by section 503B(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

2Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.

3Labeling and packaging

The container of your outsourcing facility's drug products does not include information required by section 503B(a)(10)(8) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

4Process validation

Your fir m 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.

5Labeling and packaging

The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(1 0)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

About this record

Extracted automatically from the document US FDA published on 2025-02-07. 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.

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