Galentic Pharma (India) Pvt. Ltd — Gandhidham
USFDA inspection record for FEI 3012178852, Gandhidham, India.
VAI
Latest classification
2
Inspections on record
5
Form 483 observations on record
History (newest first)
Inspections
11 Aug 2026
VAI — Voluntary action indicated
Drug Quality Assurance · Drugs · FY2026
Source: FDA Data Dashboard ↗
08 Dec 2022
VAI — Voluntary action indicated
Drug Quality Assurance · Drugs · FY2023
Form 483: 5 observations
- Valid stability test methods (21 CFR 211.166(a)(3))
- Backup file not maintained (21 CFR 211.68(b))
- Training--operations, GMPs, written procedures (21 CFR 211.25(a))
- Authority lacking to review records, investigate errors (21 CFR 211.22(a))
- Testing and release for distribution (21 CFR 211.165(a))
Source: FDA Data Dashboard ↗
📎 Cite this data: Source: PharmaRoz, FDA inspection record for FEI 3012178852, updated 12 Nov 2026