Perry Drug
Form 483 issued September 9, 2014 · Overland Park, Kansas
- Inspection
- Aug 26 – Sep 9, 2014
- Investigator
- Michele L. Obert
- Observations
- 6
- Pages
- 4
- FEI number
- 3011000002
In short: On September 9, 2014, FDA issued a Form 483 with 6 observations to Perry Drug in Overland Park, Kansas (FEI 3011000002) after an inspection that ran Aug 26 – Sep 9, 2014. The investigator was Michele L. Obert. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Michele L. Obert
6 documents · 2012–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kansas.
The firmPerry Drug history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Perry Drug?
FDA listed 6 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. 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 Perry Drug?
Michele L. Obert is named on this Form 483, for the inspection of Aug 26 – Sep 9, 2014. Each investigator has a profile showing what they cite most.
When was Perry Drug inspected by FDA?
The inspection ran Aug 26 – Sep 9, 2014, and the Form 483 is dated September 9, 2014.
How do I get the full Form 483 for Perry Drug?
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.