Biocon Limited
Form 483 issued July 20, 2022 · Sangareddy, India
- Inspection
- Jul 13 – Jul 20, 2022
- Observations
- 3
- Pages
- 2
- FEI number
- 3004956855
In short: On July 20, 2022, FDA issued a Form 483 with 3 observations to Biocon Limited in Sangareddy, Telangana (FEI 3004956855) after an inspection that ran Jul 13 – Jul 20, 2022. Most observations concern facilities & equipment and materials.
At a glance
Facilities & equipment and materials account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory control mechanisms are deficient in ensuring that raw data generated and backed up…
- 02
There is failure to adequately monitor critical storage parameters and areas that could potentially impact the…
- 03
Deviations from established procedures were…
This inspection in context
Questions about this 483
What did FDA find at Biocon Limited?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, materials and production. The opening words of each observation are shown on this page.
When was Biocon Limited inspected by FDA?
The inspection ran Jul 13 – Jul 20, 2022, and the Form 483 is dated July 20, 2022.
How do I get the full Form 483 for Biocon 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.