Strides Shasun Limited KRS Gardens, Suragajakkanhalli
Form 483 issued May 26, 2017 · Bangalore South, India
- Inspection
- May 22 – May 26, 2017
- Investigators
- Darren S. Brown· Tamil Arasu
- Observations
- 1
- Pages
- 4
- FEI number
- 3004554612
In short: On May 26, 2017, FDA issued a Form 483 with 1 observation to Strides Shasun Limited KRS Gardens, Suragajakkanhalli in Bangalore South, India (FEI 3004554612) after an inspection that ran May 22 – May 26, 2017. The investigators were Darren S. Brown and Tamil Arasu. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
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 211.192
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 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Strides Shasun Limited KRS Gardens, Suragajakkanhalli?
Darren S. Brown and Tamil Arasu are named on this Form 483, for the inspection of May 22 – May 26, 2017. 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 22 – May 26, 2017, and the Form 483 is dated May 26, 2017.
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.