Strohecker's Pharmacy
Form 483 issued October 4, 2016 · Portland, Oregon
- Inspection
- Sep 26 – Oct 4, 2016
- Investigators
- Darren S. Brown· Jeffery A. Johnson
- Observations
- 4
- Pages
- 5
- FEI number
- 3003429652
In short: On October 4, 2016, FDA issued a Form 483 with 4 observations to Strohecker's Pharmacy in Portland, Oregon (FEI 3003429652) after an inspection that ran Sep 26 – Oct 4, 2016. The investigators were Darren S. Brown and Jeffery A. Johnson. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 4 of 4 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
- 04
Master production and control records lack complete…
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmStrohecker's Pharmacy history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Strohecker's Pharmacy?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and production. 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 Strohecker's Pharmacy?
Darren S. Brown and Jeffery A. Johnson are named on this Form 483, for the inspection of Sep 26 – Oct 4, 2016. Each investigator has a profile showing what they cite most.
When was Strohecker's Pharmacy inspected by FDA?
The inspection ran Sep 26 – Oct 4, 2016, and the Form 483 is dated October 4, 2016.
How do I get the full Form 483 for Strohecker's Pharmacy?
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.