Clongen Laboratories, LLC
FDA inspection history in Gaithersburg, Maryland, 2025
- 1
- Form 483
Every document, by year
- Form 483
2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2025One Form 483, at Gaithersburg, Maryland.
Cited most
Across all Clongen Laboratories observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Clongen Laboratories file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Gaithersburg, Maryland
One Form 483 · 2025 · 2 observations
Latest: Form 483, Jun 17, 2025 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-06-17 | 483 Form 483 | Gaithersburg, Maryland | 2 | $99 |
Investigators on these documents
Carl Perez (1)Donald Ertel (1)Hyesuk Kong (1)Kevin Matthews (1)
FEI number 3006579817 · most recent document Jun 17, 2025
About Clongen Laboratories, LLC
How many FDA Form 483s has Clongen Laboratories, LLC received?
FDA Intel has 1 Form 483 on file for Clongen Laboratories, LLC; the most recent is dated Jun 17, 2025.
When was Clongen Laboratories, LLC last inspected by FDA?
The most recent FDA inspection document on file for Clongen Laboratories, LLC is a Form 483 dated Jun 17, 2025, for the site in Gaithersburg, Maryland.
What did FDA cite at Clongen Laboratories, LLC?
The regulations cited most in the observations on file for Clongen Laboratories, LLC are 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.