Inspection Record

Scientific Protein Laboratories — FDA 483 Findings

US FDAInspected 2015-07-11Published 2024-01-17 3 findingsEquipment and facilityComplaint and recall handlingMaterial and supplier control

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

Findings

1Equipment and facility

Equipment used in the manufacture (b) (4) ofAPI intennediates is not ofappropriate design and has not been qualified to ensure it does not alter the quality ofthe intennediate or API.

2Complaint and recall handling

You did not adequately investigate a complaint that affected product quality and did not extend the investigation to other lots that may have been associated with the complaint.

3Material and supplier control

You did not adequately evaluate your suppliers of raw ingredients.

About this record

Extracted automatically from the document US FDA published on 2024-01-17. 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

2015-07-11 · US FDA · 9 findings
Scientific Protein Laboratories findings history — including this company's other documents US FDA documents, 2024 Go to Findings search