Strides Shasun Limited KRS Gardens, Suragajakkanhalli
Form 483 issued August 24, 2018 · Bengaluru, India
- Inspection
- Aug 20 – Aug 24, 2018
- Investigator
- Andrew J. Idzior
- Observations
- 1
- Pages
- 2
- FEI number
- 3004554612
In short: On August 24, 2018, FDA issued a Form 483 with 1 observation to Strides Shasun Limited KRS Gardens, Suragajakkanhalli in Bengaluru, India (FEI 3004554612) after an inspection that ran Aug 20 – Aug 24, 2018. The investigator was Andrew J. Idzior. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment…
This inspection in context
Andrew J. Idzior
6 documents · 2013–2018
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 211.67
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 facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Strides Shasun Limited KRS Gardens, Suragajakkanhalli?
Andrew J. Idzior is named on this Form 483, for the inspection of Aug 20 – Aug 24, 2018. Each investigator has a profile showing what they cite most.
When was Strides Shasun Limited KRS Gardens, Suragajakkanhalli inspected by FDA?
The inspection ran Aug 20 – Aug 24, 2018, and the Form 483 is dated August 24, 2018.
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.