Exelead, Inc.
Form 483 issued December 20, 2023 · Indianapolis, Indiana
- Inspection
- Dec 11 – Dec 20, 2023
- Observations
- 9
- Pages
- 11
- FEI number
- 1000517970
In short: On December 20, 2023, FDA issued a Form 483 with 9 observations to Exelead, Inc. in Indianapolis, Indiana (FEI 1000517970) after an inspection that ran Dec 11 – Dec 20, 2023. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 7 of 9 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Employees engaged in the manufacture and processing of a drug product lack the training required to…
This inspection in context
Questions about this 483
What did FDA find at Exelead, Inc.?
FDA listed 9 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
When was Exelead, Inc. inspected by FDA?
The inspection ran Dec 11 – Dec 20, 2023, and the Form 483 is dated December 20, 2023.
How do I get the full Form 483 for Exelead, Inc.?
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.