Buderer Drug Company
Form 483 issued February 14, 2019 · Avon, Ohio
- Inspection
- Feb 7 – Feb 14, 2019
- Investigator
- Jazmine N. Still
- Observations
- 1
- Pages
- 1
- FEI number
- 3011838368
In short: On February 14, 2019, FDA issued a Form 483 with 1 observation to Buderer Drug Company in Avon, Ohio (FEI 3011838368) after an inspection that ran Feb 7 – Feb 14, 2019. The investigator was Jazmine N. Still. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
This inspection in context
Jazmine N. Still
16 documents · 2017–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmBuderer Drug Company history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Buderer Drug Company?
FDA listed 1 observation on this Form 483, mostly about materials. 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 Buderer Drug Company?
Jazmine N. Still is named on this Form 483, for the inspection of Feb 7 – Feb 14, 2019. Each investigator has a profile showing what they cite most.
When was Buderer Drug Company inspected by FDA?
The inspection ran Feb 7 – Feb 14, 2019, and the Form 483 is dated February 14, 2019.
How do I get the full Form 483 for Buderer Drug Company?
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.