FDA Inspection 1259977 - PIOUS LABORATORIES PRIVATE LIMITED - February 05, 2025

Record Details

This FDA Inspection record concerns PIOUS LABORATORIES PRIVATE LIMITED, with an inspection on February 5, 2025, issued by the Office of Inspections and Investigations, covering human drugs.

Company: PIOUS LABORATORIES PRIVATE LIMITED
Inspection Date: February 5, 2025
Product Type: Human Drugs
Office: Office of Inspections and Investigations
Person: Kayla V. Sprague (FDA Associated Person)

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ID · 67c7067b-9d3d-47f4-8428-d1f6749a3fbb

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1259977
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 211.22(a)Authority lacking to review records, investigate errors

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FDA Inspection

PIOUS LABORATORIES PRIVATE LIMITEDFebruary 5, 2025