Sidmak Laboratories (India) Pvt.Ltd.
Form 483 issued May 13, 2023 · Dehradun, India
- Inspection
- May 8 – May 13, 2023
- Investigator
- Dipesh K. Shah
- Observations
- 3
- Pages
- 4
- FEI number
- 3008127341
In short: On May 13, 2023, FDA issued a Form 483 with 3 observations to Sidmak Laboratories (India) Pvt.Ltd. in Dehradun, Uttarakhand (FEI 3008127341) after an inspection that ran May 8 – May 13, 2023. The investigator was Dipesh K. Shah. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (2×) · 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Qualification of equipment is…
- 02
Appropriate controls governing computer acquired data and/or related systems have not been established to assure that…
- 03
You have failed to properly validate your…
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 firmSidmak Laboratories (India) Pvt.Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sidmak Laboratories (India) Pvt.Ltd.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Sidmak Laboratories (India) Pvt.Ltd.?
Dipesh K. Shah is named on this Form 483, for the inspection of May 8 – May 13, 2023. Each investigator has a profile showing what they cite most.
When was Sidmak Laboratories (India) Pvt.Ltd. inspected by FDA?
The inspection ran May 8 – May 13, 2023, and the Form 483 is dated May 13, 2023.
How do I get the full Form 483 for Sidmak Laboratories (India) Pvt.Ltd.?
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