Biocon Limited
Form 483 issued March 5, 2019 · Bengaluru, India
- Inspection
- Feb 25 – Mar 5, 2019
- Observations
- 6
- Pages
- 4
- FEI number
- 1000172912
In short: On March 5, 2019, FDA issued a Form 483 with 6 observations to Biocon Limited in Bengaluru, Karnataka (FEI 1000172912) after an inspection that ran Feb 25 – Mar 5, 2019. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 4 of 6 observations.
Most cited: 21 CFR 211.160 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are discrepancies between the information submitted in DMF | and the manufacturing process…
- 02
The firm’s bacterial endotoxin test (Gel-Clot method) for™™ finished…
- 03
The environmental monitoring of clean rooms by…
- 04
Laboratory coiitrols failed to ensure that the Empower chromatographic system software appropriately feports the quality characteristics…
This inspection in context
Questions about this 483
What did FDA find at Biocon Limited?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Biocon Limited inspected by FDA?
The inspection ran Feb 25 – Mar 5, 2019, and the Form 483 is dated March 5, 2019.
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.