Elba, Inc.
Form 483 issued May 13, 2025 · Troy, Michigan
- Inspection
- May 5 – May 13, 2025
- Investigators
- Joohi Castelvetere· Melissa M. Steiger
- Observations
- 9
- Pages
- 23
- FEI number
- 1000115351
In short: On May 13, 2025, FDA issued a Form 483 with 9 observations to Elba, Inc. in Troy, Michigan (FEI 1000115351) after an inspection that ran May 5 – May 13, 2025. The investigators were Joohi Castelvetere and Melissa M. Steiger. Most observations concern packaging & labeling; the most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria).
At a glance
1 of 1 observations on this 483 concern packaging & labeling.
Most cited: 21 CFR 211.122 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Labeling and packaging materials are not representatively sampled and examined upon receipt and before use in…
This inspection in context
Joohi Castelvetere
9 documents · 2024–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Indiana.
The firmElba, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.122
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Elba, Inc.?
FDA listed 9 observations on this Form 483, mostly about packaging & labeling. The most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria). The opening words of each observation are shown on this page.
Who inspected Elba, Inc.?
Joohi Castelvetere and Melissa M. Steiger are named on this Form 483, for the inspection of May 5 – May 13, 2025. Each investigator has a profile showing what they cite most.
When was Elba, Inc. inspected by FDA?
The inspection ran May 5 – May 13, 2025, and the Form 483 is dated May 13, 2025.
How do I get the full Form 483 for Elba, 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.