M/S, Sygmoslab Private Limited – FDA Inspection, Sep 26, 2025

Record Details

This FDA Inspection record concerns M/S, Sygmoslab Private Limited, with an inspection on September 26, 2025, issued by the Office of Inspections and Investigations, covering human drugs.

Company: M/S, Sygmoslab Private Limited
Inspection Date: September 26, 2025
Product Type: Human Drugs
Office: Office of Inspections and Investigations
People: Pratik S. Upadhyay (FDA Associated Person)
Rafeeq A. Habeeb (FDA Associated Person)
Saleem A. Akhtar

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ID · 3080f3cd-5859-4964-bef2-503d79306a13

Inspection Facts

Inspection number: 1284922
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.180(c)Records not made readily available to FDA
21 CFR 211.22(d)Procedures not in writing, fully followed
21 CFR 211.68(b)Computer control of master formula records

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FDA Inspection

M/S, Sygmoslab Private LimitedSeptember 26, 2025