Strohecker's Pharmacy
Form 483 issued November 27, 2019 · Portland, Oregon
- Inspection
- Nov 21 – Nov 27, 2019
- Investigator
- Anita Narula
- Observations
- 4
- Pages
- 3
- FEI number
- 3003429652
In short: On November 27, 2019, FDA issued a Form 483 with 4 observations to Strohecker's Pharmacy in Portland, Oregon (FEI 3003429652) after an inspection that ran Nov 21 – Nov 27, 2019. The investigator was Anita Narula. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 4 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×) · 211.28 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Protective apparel is not worn as necessary to protect…
- 02
ISO-5 classified areas were not…
- 03
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
- 04
Non-pharmaceutical grade components are used in the formulation…
This inspection in context
Anita Narula
13 documents · 2014–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Oregon.
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 211.113
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 production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Strohecker's Pharmacy?
Anita Narula is named on this Form 483, for the inspection of Nov 21 – Nov 27, 2019. Each investigator has a profile showing what they cite most.
When was Strohecker's Pharmacy inspected by FDA?
The inspection ran Nov 21 – Nov 27, 2019, and the Form 483 is dated November 27, 2019.
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.