Strides Shasun Limited KRS Gardens, Suragajakkanhalli
Form 483 issued May 24, 2019 · Bengaluru, India
- Inspection
- May 16 – May 24, 2019
- Investigator
- Rumany C. Penn
- Observations
- 4
- Pages
- 4
- FEI number
- 3004554612
In short: On May 24, 2019, FDA issued a Form 483 with 4 observations to Strides Shasun Limited KRS Gardens, Suragajakkanhalli in Bengaluru, Karnataka (FEI 3004554612) after an inspection that ran May 16 – May 24, 2019. The investigator was Rumany C. Penn. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 3 of 4 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
- 03
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
This inspection in context
Rumany C. Penn
21 documents · 2016–2022
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 4 observations on this Form 483, mostly about quality system, production and laboratory controls. 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?
Rumany C. Penn is named on this Form 483, for the inspection of May 16 – May 24, 2019. 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 16 – May 24, 2019, and the Form 483 is dated May 24, 2019.
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.