Symed Labs Limited
Form 483 issued October 16, 2021 · Yadadri Bhuvangiri, India
- Inspection
- Oct 11 – Oct 16, 2021
- Investigator
- Nancy M. Espinal
- Observations
- 3
- Pages
- 3
- FEI number
- 3015443266
In short: On October 16, 2021, FDA issued a Form 483 with 3 observations to Symed Labs Limited in Yadadri Bhuvangiri, Telangana (FEI 3015443266) after an inspection that ran Oct 11 – Oct 16, 2021. The investigator was Nancy M. Espinal. Most observations concern facilities & equipment and laboratory controls.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment is not cleaned or maintained at appropriate intervals to prevent malfunctions or contamination that would…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Appropriate installation and operational qualifications should demonstrate the suitability of computer hardware and software to perform…
This inspection in context
Nancy M. Espinal
16 documents · 2016–2022
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmSymed Labs Limited history
The site's inspection history, in date order.
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 Symed Labs Limited?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Symed Labs Limited?
Nancy M. Espinal is named on this Form 483, for the inspection of Oct 11 – Oct 16, 2021. Each investigator has a profile showing what they cite most.
When was Symed Labs Limited inspected by FDA?
The inspection ran Oct 11 – Oct 16, 2021, and the Form 483 is dated October 16, 2021.
How do I get the full Form 483 for Symed Labs 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.