Buderer Drug Company Inc.
Form 483 issued July 24, 2017 · Penysburg, Ohio
- Inspection
- Jul 17 – Jul 24, 2017
- Investigators
- Jazmine N. Still· Matthew B. Casale
- Observations
- 3
- Pages
- 1
- FEI number
- 3005664940
In short: On July 24, 2017, FDA issued a Form 483 with 3 observations to Buderer Drug Company Inc. in Penysburg, Ohio (FEI 3005664940) after an inspection that ran Jul 17 – Jul 24, 2017. The investigators were Jazmine N. Still and Matthew B. Casale. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm released drug product in which the strength differs from, or its purity or quality…
- 02
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to…
- 03
Pressure differentials between areas with different air classifications were not monitored prior to or…
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 Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Buderer Drug Company Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Buderer Drug Company Inc.?
Jazmine N. Still and Matthew B. Casale are named on this Form 483, for the inspection of Jul 17 – Jul 24, 2017. Each investigator has a profile showing what they cite most.
When was Buderer Drug Company Inc. inspected by FDA?
The inspection ran Jul 17 – Jul 24, 2017, and the Form 483 is dated July 24, 2017.
How do I get the full Form 483 for Buderer Drug Company 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.