Strides Pharma Science Limited
Form 483 issued February 24, 2023 · Puducherry, India
- Inspection
- Feb 20 – Feb 24, 2023
- Investigators
- Dipesh K. Shah· Yvins Dezan
- Observations
- 5
- Pages
- 14
- FEI number
- 3012448465
In short: On February 24, 2023, FDA issued a Form 483 with 5 observations to Strides Pharma Science Limited in Puducherry, Puducherry (FEI 3012448465) after an inspection that ran Feb 20 – Feb 24, 2023. The investigators were Dipesh K. Shah and Yvins Dezan. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and…
- 04
Master production and control records lack complete manufacturing and control instructions, special notations and…
This inspection in context
Dipesh K. Shah
29 documents · 2006–2026
Cites 211.192 (production record review) 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 5 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?
Dipesh K. Shah and Yvins Dezan are named on this Form 483, for the inspection of Feb 20 – Feb 24, 2023. Each investigator has a profile showing what they cite most.
When was Strides Pharma Science Limited inspected by FDA?
The inspection ran Feb 20 – Feb 24, 2023, and the Form 483 is dated February 24, 2023.
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.