Blount Discount Pharmacy, Inc.
Form 483 issued February 13, 2020 · Alcoa, Tennessee
- Inspection
- Feb 10 – Feb 13, 2020
- Investigator
- Claire M. Minden
- Observations
- 3
- Pages
- 1
- FEI number
- 3015826061
In short: On February 13, 2020, FDA issued a Form 483 with 3 observations to Blount Discount Pharmacy, Inc. in Alcoa, Tennessee (FEI 3015826061) after an inspection that ran Feb 10 – Feb 13, 2020. The investigator was Claire M. Minden. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×) · 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Hazardous and highly potent chugs are produced without providing adequate cleaning of work srnfaces, utensils, equipment…
- 02
Agents used for cleaning the laminai· flow hood and other equipment between products do not include…
- 03
Non-pharmaceutical grade components are used in the formulation…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
The firmBlount Discount Pharmacy, Inc. 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 Blount Discount Pharmacy, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and materials. 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 Blount Discount Pharmacy, Inc.?
Claire M. Minden is named on this Form 483, for the inspection of Feb 10 – Feb 13, 2020. Each investigator has a profile showing what they cite most.
When was Blount Discount Pharmacy, Inc. inspected by FDA?
The inspection ran Feb 10 – Feb 13, 2020, and the Form 483 is dated February 13, 2020.
How do I get the full Form 483 for Blount Discount Pharmacy, Inc.?
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.