Gehring-Montgomery, Inc.
Form 483 issued February 9, 2024 · Warminster, Pennsylvania
- Inspection
- Feb 5 – Feb 9, 2024
- Investigator
- Brandy N. Lepage
- Observations
- 3
- Pages
- 2
- FEI number
- 3000214933
In short: On February 9, 2024, FDA issued a Form 483 with 3 observations to Gehring-Montgomery, Inc. in Warminster, Pennsylvania (FEI 3000214933) after an inspection that ran Feb 5 – Feb 9, 2024. The investigator was Brandy N. Lepage. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and quality system account for 2 of 3 observations.
Most cited: 21 CFR 211.84 (1×) · 211.25 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to reject any lot of components that did not meet the appropriate written specifications for…
- 02
A system by which the distribution of each lot of drug component can be readily determined…
- 03
GMP training is not conducted on a continuing basis to assure that employees remain familiar with…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmGehring-Montgomery, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Gehring-Montgomery, Inc.?
FDA listed 3 observations on this Form 483, mostly about materials and quality system. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Gehring-Montgomery, Inc.?
Brandy N. Lepage is named on this Form 483, for the inspection of Feb 5 – Feb 9, 2024. Each investigator has a profile showing what they cite most.
When was Gehring-Montgomery, Inc. inspected by FDA?
The inspection ran Feb 5 – Feb 9, 2024, and the Form 483 is dated February 9, 2024.
How do I get the full Form 483 for Gehring-Montgomery, 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.