ARENE LIFE SCIENCES PRIVATE LIMITED
Form 483 issued August 30, 2024 · Sangareddy, India
- Inspection
- Aug 26 – Aug 30, 2024
- Investigator
- Bryan L. McGuckin
- Observations
- 2
- Pages
- 2
- FEI number
- 3013438177
In short: On August 30, 2024, FDA issued a Form 483 with 2 observations to ARENE LIFE SCIENCES PRIVATE LIMITED in Sangareddy, Telangana (FEI 3013438177) after an inspection that ran Aug 26 – Aug 30, 2024. The investigator was Bryan L. McGuckin. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Inspection of electronic equipment is not performed according to a written program designed…
- 02
Specifically, Review of equipment usage log books for both Equipment ID: ALS/QCD/G GC/006 had no entry…
This inspection in context
Bryan L. McGuckin
30 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmARENE LIFE SCIENCES PRIVATE LIMITED history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ARENE LIFE SCIENCES PRIVATE LIMITED?
FDA listed 2 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 ARENE LIFE SCIENCES PRIVATE LIMITED?
Bryan L. McGuckin is named on this Form 483, for the inspection of Aug 26 – Aug 30, 2024. Each investigator has a profile showing what they cite most.
When was ARENE LIFE SCIENCES PRIVATE LIMITED inspected by FDA?
The inspection ran Aug 26 – Aug 30, 2024, and the Form 483 is dated August 30, 2024.
How do I get the full Form 483 for ARENE LIFE SCIENCES 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.