Elba, Inc.
FDA inspection history in Troy, Michigan, 2017 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Troy, Michigan.
- 2025One Form 483, at Troy, Michigan.
- 2025The longest 483 on file: 9 observations over 23 pages at Troy, Michigan.
Cited most
Across all Elba observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.122Materials examination and usage criteria1
- 21 CFR 211.180(e)(2)General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete Elba file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Troy, Michigan
Two Form 483s · 2017 to 2025 · 14 observations
Latest: Form 483, May 13, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-05-13 | 483 Form 483 | Troy, Michigan | 9 | $99 |
| 2017-10-05 | 483 Form 483 | Troy, Michigan | 5 | $99 |
Investigators on these documents
Emilie Kahn (1)Joohi Castelvetere (1)Melissa M. Steiger (1)Michelle L. Jones (1)
FEI number 1000115351 · most recent document May 13, 2025
About Elba, Inc.
How many FDA Form 483s has Elba, Inc. received?
FDA Intel has 2 Form 483s on file for Elba, Inc.; the most recent is dated May 13, 2025.
When was Elba, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Elba, Inc. is a Form 483 dated May 13, 2025, for the site in Troy, Michigan.
What did FDA cite at Elba, Inc.?
The regulations cited most in the observations on file for Elba, Inc. are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.122 (Materials examination and usage criteria), 1 time; 21 CFR 211.180(e)(2) (General requirements), 1 time.