Unexo Life Sciences Private Ltd.
Form 483 issued May 14, 2024 · New Delhi, India
- Inspection
- May 1 – May 14, 2024
- Investigators
- Kellia N. Hicks· Nicole E. Knowlton
- Observations
- 12
- Pages
- 15
- FEI number
- 3013514280
In short: On May 14, 2024, FDA issued a Form 483 with 12 observations to Unexo Life Sciences Private Ltd. in New Delhi, Delhi (FEI 3013514280) after an inspection that ran May 1 – May 14, 2024. The investigators were Kellia N. Hicks and Nicole E. Knowlton. Most observations concern facilities & equipment and quality system.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any…
- 03
The accuracy, sensitivity, specificity, and reproducibility of test methods have not…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmUnexo Life Sciences Private Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Unexo Life Sciences Private Ltd.?
FDA listed 12 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Unexo Life Sciences Private Ltd.?
Kellia N. Hicks and Nicole E. Knowlton are named on this Form 483, for the inspection of May 1 – May 14, 2024. Each investigator has a profile showing what they cite most.
When was Unexo Life Sciences Private Ltd. inspected by FDA?
The inspection ran May 1 – May 14, 2024, and the Form 483 is dated May 14, 2024.
How do I get the full Form 483 for Unexo Life Sciences Private Ltd.?
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.