Biocon Sdn Bhd
Form 483 issued February 21, 2020 · Iskandar Puteri, Malaysia
- Inspection
- Feb 10 – Feb 21, 2020
- Investigators
- Shawn E. Larson· Vidya B. Pai
- Observations
- 3
- Pages
- 3
- FEI number
- 3011248248
In short: On February 21, 2020, FDA issued a Form 483 with 3 observations to Biocon Sdn Bhd in Iskandar Puteri, Johor (FEI 3011248248) after an inspection that ran Feb 10 – Feb 21, 2020. The investigators were Shawn E. Larson and Vidya B. Pai. Most observations concern quality system and production.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Shawn E. Larson
8 documents · 2015–2020
Cites 211.160(a) (general requirements) more than any other section. Most of their documents are for sites in Texas.
The firmBiocon Sdn Bhd history
All 6 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 Biocon Sdn Bhd?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected Biocon Sdn Bhd?
Shawn E. Larson and Vidya B. Pai are named on this Form 483, for the inspection of Feb 10 – Feb 21, 2020. Each investigator has a profile showing what they cite most.
When was Biocon Sdn Bhd inspected by FDA?
The inspection ran Feb 10 – Feb 21, 2020, and the Form 483 is dated February 21, 2020.
How do I get the full Form 483 for Biocon Sdn Bhd?
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.