Exelead, Inc.
FDA inspection history in Indianapolis, Indiana, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Indianapolis, Indiana.
Cited most
Across all Exelead observations on file
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.192Production record review1
- 21 CFR 211.198Complaint files1
The complete Exelead file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Indianapolis, Indiana
One Form 483 · 2023 · 9 observations
Latest: Form 483, Dec 20, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-12-20 | 483 Form 483 | Indianapolis, Indiana | 9 | $99 |
FEI number 1000517970 · most recent document Dec 20, 2023
About Exelead, Inc.
How many FDA Form 483s has Exelead, Inc. received?
FDA Intel has 1 Form 483 on file for Exelead, Inc.; the most recent is dated Dec 20, 2023.
When was Exelead, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Exelead, Inc. is a Form 483 dated Dec 20, 2023, for the site in Indianapolis, Indiana.
What did FDA cite at Exelead, Inc.?
The regulations cited most in the observations on file for Exelead, Inc. are 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.188 (Batch production and control records), 1 time.