Loop Pharmacy & Home Medical
Form 483 issued September 25, 2018 · Saint Albans, West Virginia
- Inspection
- Sep 19 – Sep 25, 2018
- Investigator
- Melissa T. Roy
- Observations
- 4
- Pages
- 2
- FEI number
- 3004610520
In short: On September 25, 2018, FDA issued a Form 483 with 4 observations to Loop Pharmacy & Home Medical in Saint Albans, West Virginia (FEI 3004610520) after an inspection that ran Sep 19 – Sep 25, 2018. The investigator was Melissa T. Roy. 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×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The ISO 5 classified area is located within a non-classified…
- 02
Non-sterilized or non-depyrogenated tools or temporary containers were used…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
This inspection in context
Melissa T. Roy
6 documents · 2016–2018
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New Jersey.
The firmLoop Pharmacy & Home Medical 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 Loop Pharmacy & Home Medical?
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 Loop Pharmacy & Home Medical?
Melissa T. Roy is named on this Form 483, for the inspection of Sep 19 – Sep 25, 2018. Each investigator has a profile showing what they cite most.
When was Loop Pharmacy & Home Medical inspected by FDA?
The inspection ran Sep 19 – Sep 25, 2018, and the Form 483 is dated September 25, 2018.
How do I get the full Form 483 for Loop Pharmacy & Home Medical?
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.