WINDLAS BIOTECH LIMITED
Form 483 issued August 30, 2019 · Dehradun, India
- Inspection
- Aug 26 – Aug 30, 2019
- Investigators
- Arsen Karapetyan· Pratik S. Upadhyay
- Observations
- 5
- Pages
- 13
- FEI number
- 3005339091
In short: On August 30, 2019, FDA issued a Form 483 with 5 observations to WINDLAS BIOTECH LIMITED in Dehradun, India (FEI 3005339091) after an inspection that ran Aug 26 – Aug 30, 2019. The investigators were Arsen Karapetyan and Pratik S. Upadhyay. Most observations concern laboratory controls and quality system.
At a glance
3 of 5 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations from written test procedures and laboratory mechanisms are…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmWINDLAS BIOTECH LIMITED history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at WINDLAS BIOTECH LIMITED?
FDA listed 5 observations on this Form 483, mostly about laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected WINDLAS BIOTECH LIMITED?
Arsen Karapetyan and Pratik S. Upadhyay are named on this Form 483, for the inspection of Aug 26 – Aug 30, 2019. Each investigator has a profile showing what they cite most.
When was WINDLAS BIOTECH LIMITED inspected by FDA?
The inspection ran Aug 26 – Aug 30, 2019, and the Form 483 is dated August 30, 2019.
How do I get the full Form 483 for WINDLAS BIOTECH LIMITED?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.