Pure Tropic — Chengappalli
USFDA inspection record for FEI 3013361517, Chengappalli, India.
OAI
Latest classification
1
Inspections on record
7
Form 483 observations on record
History (newest first)
Inspections
14 Aug 2024
OAI — Official action indicated
Foodborne Biological Hazards · Food/Cosmetics · FY2024
Form 483: 7 observations
- Present each sterilizer, accurate (21 CFR 113.40(g)(1)(i)(B))
- Recording device - flow rate, temperature, concentration (21 CFR 113.40(g)(2)(i)(A))
- Unauthorized flow adjustments (21 CFR 113.40(g)(1)(i)(F))
- Operating processes not posted (21 CFR 113.87(a))
- No accurate TID (21 CFR 113.40(g)(1)(i)(A))
- Supervisors (21 CFR 113.10)
- Aseptic processing: TID not accurate to 1° F (21 CFR 113.40(g)(1)(i)(A)(4))
Source: FDA Data Dashboard ↗
📎 Cite this data: Source: PharmaRoz, FDA inspection record for FEI 3013361517, updated 12 Nov 2026