OrBion Pharmaceuticals Private Limited
Form 483 issued September 8, 2023 · Sriperumbudur, India
- Inspection
- Aug 31 – Sep 8, 2023
- Investigators
- Lillian S. Wu· Nicole E. Knowlton
- Observations
- 3
- Pages
- 3
- FEI number
- 3004540907
In short: On September 8, 2023, FDA issued a Form 483 with 3 observations to OrBion Pharmaceuticals Private Limited in Sriperumbudur, Tamil Nadu (FEI 3004540907) after an inspection that ran Aug 31 – Sep 8, 2023. The investigators were Lillian S. Wu and Nicole E. Knowlton. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Established specifications, standards and laboratory control…
This inspection in context
Lillian S. Wu
11 documents · 2022–2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmOrBion Pharmaceuticals Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OrBion Pharmaceuticals Private Limited?
FDA listed 3 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected OrBion Pharmaceuticals Private Limited?
Lillian S. Wu and Nicole E. Knowlton are named on this Form 483, for the inspection of Aug 31 – Sep 8, 2023. Each investigator has a profile showing what they cite most.
When was OrBion Pharmaceuticals Private Limited inspected by FDA?
The inspection ran Aug 31 – Sep 8, 2023, and the Form 483 is dated September 8, 2023.
How do I get the full Form 483 for OrBion Pharmaceuticals Private 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.