Sun Pharmaceutical Industries Ltd. — Halol
USFDA inspection record for FEI 3002809586, Halol, India. Listed company: Sun Pharmaceutical Industries.
OAI
Latest classification
2
Inspections on record
5
Form 483 observations on record
History (newest first)
Inspections
13 Jun 2025
OAI — Official action indicated
Drug Quality Assurance · Drugs · FY2025
Source: FDA Data Dashboard ↗
09 May 2022
OAI — Official action indicated
Drug Quality Assurance · Drugs · FY2022
Form 483: 5 observations
- Aseptic Processing Area (21 CFR 211.42(c)(10))
- Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
- Written program not followed (21 CFR 211.166(a))
- Equipment Design, Size and Location (21 CFR 211.63)
- Scientifically sound laboratory controls (21 CFR 211.160(b))
Source: FDA Data Dashboard ↗
FDA compliance actions
| Date | Action | Product type |
|---|---|---|
| 15 Dec 2022 | Warning Letter | Drugs |
📎 Cite this data: Source: PharmaRoz, FDA inspection record for FEI 3002809586, updated 12 Nov 2026