Strides Shasun Limited KRS Gardens, Suragajakkanhalli
Form 483 issued December 5, 2020 · Bangalore, India
- Inspection
- May 12 – May 20, 2026
- Investigators
- Lisa L. Flores· Rafeeq Habeeb
- Observations
- 5
- Pages
- 17
- FEI number
- 3004554612
In short: On December 5, 2020, FDA issued a Form 483 with 5 observations to Strides Shasun Limited KRS Gardens, Suragajakkanhalli in Bangalore, India (FEI 3004554612) after an inspection that ran May 12 – May 20, 2026. The investigators were Lisa L. Flores and Rafeeq Habeeb. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and…
- 02
All records of production associated with a batch of drug product were not maintained at least…
- 03
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 04
Your firm failed to exercise controls over computerized manufacturing equipment to ensure that only authorized personnel…
This inspection in context
Lisa L. Flores
20 documents · 2012–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmStrides Shasun Limited KRS Gardens, Suragajakkanhalli history
All 5 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 Strides Shasun Limited KRS Gardens, Suragajakkanhalli?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Strides Shasun Limited KRS Gardens, Suragajakkanhalli?
Lisa L. Flores and Rafeeq Habeeb are named on this Form 483, for the inspection of May 12 – May 20, 2026. Each investigator has a profile showing what they cite most.
When was Strides Shasun Limited KRS Gardens, Suragajakkanhalli inspected by FDA?
The inspection ran May 12 – May 20, 2026, and the Form 483 is dated December 5, 2020.
How do I get the full Form 483 for Strides Shasun Limited KRS Gardens, Suragajakkanhalli?
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.