Strides Pharma Science Limited
Form 483 issued February 5, 2019 · Puducherry, India
- Inspection
- Jan 28 – Feb 5, 2019
- Investigators
- Jogy George· Yvins Dezan
- Observations
- 8
- Pages
- 12
- FEI number
- 3012448465
In short: On February 5, 2019, FDA issued a Form 483 with 8 observations to Strides Pharma Science Limited in Puducherry, Puducherry (FEI 3012448465) after an inspection that ran Jan 28 – Feb 5, 2019. The investigators were Jogy George and Yvins Dezan. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Employees engaged in the manufacture and packing of a drug product lack the training and experience…
- 03
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination…
- 04
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix…
This inspection in context
Jogy George
15 documents · 2016–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in India.
The firmStrides Pharma Science Limited history
All 4 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 Pharma Science Limited?
FDA listed 8 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Strides Pharma Science Limited?
Jogy George and Yvins Dezan are named on this Form 483, for the inspection of Jan 28 – Feb 5, 2019. Each investigator has a profile showing what they cite most.
When was Strides Pharma Science Limited inspected by FDA?
The inspection ran Jan 28 – Feb 5, 2019, and the Form 483 is dated February 5, 2019.
How do I get the full Form 483 for Strides Pharma Science Limited?
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.