Apex Pharmacy, LLC
Form 483 issued November 7, 2019 · Beckley, West Virginia
- Inspection
- Nov 4 – Nov 7, 2019
- Investigator
- Marcellinus D. Dordunoo
- Observations
- 3
- Pages
- 1
- FEI number
- 3012958560
In short: On November 7, 2019, FDA issued a Form 483 with 3 observations to Apex Pharmacy, LLC in Beckley, West Virginia (FEI 3012958560) after an inspection that ran Nov 4 – Nov 7, 2019. The investigator was Marcellinus D. Dordunoo. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 2 of 3 observations.
Most cited: 21 CFR 211.67 (1×) · 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
Non-phannaceutical grade components are used in the formulation…
- 02
Non-microbial contamination was observed…
- 03
Personnel engaged in aseptic processing were…
This inspection in context
Marcellinus D. Dordunoo
21 documents · 2017–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Maryland.
The firmApex Pharmacy, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apex Pharmacy, LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Apex Pharmacy, LLC?
Marcellinus D. Dordunoo is named on this Form 483, for the inspection of Nov 4 – Nov 7, 2019. Each investigator has a profile showing what they cite most.
When was Apex Pharmacy, LLC inspected by FDA?
The inspection ran Nov 4 – Nov 7, 2019, and the Form 483 is dated November 7, 2019.
How do I get the full Form 483 for Apex Pharmacy, LLC?
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.