Company
IndiaSidmak Laboratories India Pvt Ltd, Dehradun, India – FDA Inspections
Inspection records and compliance data for Sidmak Laboratories India Pvt Ltd in Dehradun. 6 FDA inspections on record (1 OAI), 3 Form 483s, last inspected May 13, 2023.
Company Profile
This profile covers Sidmak Laboratories India Pvt Ltd based in Dehradun, India.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 3
- NAI
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected October 26, 2012. Last inspected May 13, 2023.
Most cited issue areas
- Investigations of discrepancies, failures1 inspection
- No written record of investigation1 inspection
- Procedures not in writing, fully followed1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 13, 2023 | NAI | Human Drugs · Drug Quality Assurance | 1207996 |
| February 14, 2020 | NAI | Human Drugs · Drug Quality Assurance | 1123559 |
| September 6, 2019 | OAI | Human Drugs · Generic Drug Evaluation | 1102227 |
| March 31, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1009631 |
| June 6, 2014 | VAI | Human Drugs · Drug Quality Assurance | 881291 |
| October 26, 2012 | VAI | Human Drugs · Drug Quality Assurance | 806835 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
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Company Information
Name
Sidmak Laboratories India Pvt Ltd
FEI Number
3008127341
Address
Plot No. 20 Pharma City, Selaqui Ind. Area, Vikas Nagar, Dehradun, India
Country
India
ID: 2728534a-42a6-48f9-af65-6e6c302663a9