Strides Shasun Limited KRS Gardens, Suragajakkanhalli
Form 483 issued December 9, 2022 · Bengaluru, India
- Inspection
- Dec 5 – Dec 9, 2022
- Investigators
- Jose E. Melendez· Pratik S. Upadhyay
- Observations
- 3
- Pages
- 8
- FEI number
- 3004554612
In short: On December 9, 2022, FDA issued a Form 483 with 3 observations to Strides Shasun Limited KRS Gardens, Suragajakkanhalli in Bengaluru, Karnataka (FEI 3004554612) after an inspection that ran Dec 5 – Dec 9, 2022. The investigators were Jose E. Melendez and Pratik S. Upadhyay. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (2×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Established test procedures and laboratory control…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) 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 3 observations on this Form 483, mostly about laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Strides Shasun Limited KRS Gardens, Suragajakkanhalli?
Jose E. Melendez and Pratik S. Upadhyay are named on this Form 483, for the inspection of Dec 5 – Dec 9, 2022. Each investigator has a profile showing what they cite most.
When was Strides Shasun Limited KRS Gardens, Suragajakkanhalli inspected by FDA?
The inspection ran Dec 5 – Dec 9, 2022, and the Form 483 is dated December 9, 2022.
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.