Loop Pharmacy & Home Medical
Form 483 issued December 16, 2016 · Saint Albans, West Virginia
- Inspection
- Dec 12 – Dec 16, 2016
- Investigator
- Matthew B. Casale
- Observations
- 9
- Pages
- 5
- FEI number
- 3004610520
In short: On December 16, 2016, FDA issued a Form 483 with 9 observations to Loop Pharmacy & Home Medical in Saint Albans, West Virginia (FEI 3004610520) after an inspection that ran Dec 12 – Dec 16, 2016. The investigator was Matthew B. Casale. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the…
- 02
There is no written testing program designed to assess the stability…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for…
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 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(c)(10)(v)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Loop Pharmacy & Home Medical?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, laboratory controls 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?
Matthew B. Casale is named on this Form 483, for the inspection of Dec 12 – Dec 16, 2016. Each investigator has a profile showing what they cite most.
When was Loop Pharmacy & Home Medical inspected by FDA?
The inspection ran Dec 12 – Dec 16, 2016, and the Form 483 is dated December 16, 2016.
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.