Clongen Laboratories, LLC
Form 483 issued June 17, 2025 · Gaithersburg, Maryland
- Inspection
- Jun 16 – Jun 17, 2025
- Investigators
- Carl Perez· Donald Ertel· Hyesuk Kong
- Observations
- 2
- Pages
- 4
- FEI number
- 3006579817
In short: On June 17, 2025, FDA issued a Form 483 with 2 observations to Clongen Laboratories, LLC in Gaithersburg, Maryland (FEI 3006579817) after an inspection that ran Jun 16 – Jun 17, 2025. The investigators were Carl Perez, Donald Ertel, Hyesuk Kong and Kevin Matthews. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.22 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Quality oversight is…
- 02
Written procedures are not established…
This inspection in context
Carl Perez
7 documents · 2022–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
The firmClongen Laboratories, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Clongen Laboratories, LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Clongen Laboratories, LLC?
Carl Perez, Donald Ertel, Hyesuk Kong and Kevin Matthews are named on this Form 483, for the inspection of Jun 16 – Jun 17, 2025. Each investigator has a profile showing what they cite most.
When was Clongen Laboratories, LLC inspected by FDA?
The inspection ran Jun 16 – Jun 17, 2025, and the Form 483 is dated June 17, 2025.
How do I get the full Form 483 for Clongen Laboratories, LLC?
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.