Buderer Drug Company Inc.
Form 483 issued January 4, 2016 · Perrysburg, Ohio
- Inspection
- Dec 14, 2015 – Jan 4, 2016
- Investigator
- Matthew B. Casale
- Observations
- 5
- Pages
- 2
- FEI number
- 3005664940
In short: On January 4, 2016, FDA issued a Form 483 with 5 observations to Buderer Drug Company Inc. in Perrysburg, Ohio (FEI 3005664940) after an inspection that ran Dec 14, 2015 – Jan 4, 2016. The investigator was Matthew B. Casale. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Equipment and utensils are not maintained and sanitized at appropriate intervals to prevent contamination that would…
- 04
Approved components are not retested or reexamined as appropriate for identity, strength, quality and purity after…
This inspection in context
Matthew B. Casale
29 documents · 2015–2026
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 211.42(c)(10)(iii)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Buderer Drug Company Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, materials and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Buderer Drug Company Inc.?
Matthew B. Casale is named on this Form 483, for the inspection of Dec 14, 2015 – Jan 4, 2016. Each investigator has a profile showing what they cite most.
When was Buderer Drug Company Inc. inspected by FDA?
The inspection ran Dec 14, 2015 – Jan 4, 2016, and the Form 483 is dated January 4, 2016.
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.