Company
IndiaCaplin Steriles Limited, Gummidipoondi, India – FDA Inspections
Inspection records and compliance data for Caplin Steriles Limited in Gummidipoondi. 6 FDA inspections on record, 4 Form 483s, last inspected August 21, 2026.
Company Profile
This profile covers Caplin Steriles Limited based in Gummidipoondi, India.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 4
- Warning letters
- 0
First inspected October 28, 2016. Last inspected August 21, 2026.
Most cited issue areas
- Procedures for sterile drug products3 inspections
- Absence of Written Procedures1 inspection
- Calibration/Inspection/Checking not done1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 21, 2026 | Not classified | Human Drugs · Drug Quality Assurance | 1332422 |
| August 9, 2024 | NAI | Human Drugs · Bioresearch Monitoring | 1251882 |
| May 31, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1206610 |
| June 14, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1093164 |
| September 6, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1069411 |
| October 28, 2016 | VAI | Human Drugs · Generic Drug Evaluation | 991296 |
FDA documents
Form 483s (2)
- Form 483s · August 21, 2026
- Form 483s · June 14, 2019
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Company Information
Name
Caplin Steriles Limited
FEI Number
3005035920
Address
895 - 897 Guruvarajakandigai, Survey No 895 - 897, Gummidipoondi, India
Country
India
ID: af5b53d8-1adc-41f4-ab8d-0149b3b5b9cb