Labcorp Early Development Laboratories
Form 483 issued July 25, 2025 · Greenfield, Indiana
- Inspection
- Jul 21 – Jul 25, 2025
- Investigators
- Melissa M. Steiger· Shannon L. Maisano
- Observations
- 4
- Pages
- 5
- FEI number
- 1850039
In short: On July 25, 2025, FDA issued a Form 483 with 4 observations to Labcorp Early Development Laboratories in Greenfield, Indiana (FEI 1850039) after an inspection that ran Jul 21 – Jul 25, 2025. The investigators were Melissa M. Steiger and Shannon L. Maisano. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
The written stability program does not assure testing of the drug product in the same container-closure…
This inspection in context
Melissa M. Steiger
7 documents · 2024–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Michigan.
The firmLabcorp Early Development Laboratories history
The site's inspection history, in date order.
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 Labcorp Early Development Laboratories?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Labcorp Early Development Laboratories?
Melissa M. Steiger and Shannon L. Maisano are named on this Form 483, for the inspection of Jul 21 – Jul 25, 2025. Each investigator has a profile showing what they cite most.
When was Labcorp Early Development Laboratories inspected by FDA?
The inspection ran Jul 21 – Jul 25, 2025, and the Form 483 is dated July 25, 2025.
How do I get the full Form 483 for Labcorp Early Development Laboratories?
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.