Frontage Laboratories, Inc.
Form 483 issued April 14, 2026
- Inspection
- Apr 8 – Apr 14, 2026
- Investigator
- Junho Pak
- Observations
- 4
- Pages
- 3
- FEI number
- 3006799640
In short: On April 14, 2026, FDA issued a Form 483 with 4 observations to Frontage Laboratories, Inc. (FEI 3006799640) after an inspection that ran Apr 8 – Apr 14, 2026. The investigator was Junho Pak. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Laboratory records do not include a complete record of all data secured in the course of…
- 03
Failure to maintain a backup file of data entered into the…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmFrontage Laboratories, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Frontage Laboratories, Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Frontage Laboratories, Inc.?
Junho Pak is named on this Form 483, for the inspection of Apr 8 – Apr 14, 2026. Each investigator has a profile showing what they cite most.
When was Frontage Laboratories, Inc. inspected by FDA?
The inspection ran Apr 8 – Apr 14, 2026, and the Form 483 is dated April 14, 2026.
How do I get the full Form 483 for Frontage Laboratories, 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.