Medical Center Pharmacy, Inc.
Form 483 issued April 9, 2020 · Cleveland, Tennessee
- Inspection
- Mar 9 – Apr 9, 2020
- Investigators
- Demario L. Walls· June P. Page
- Observations
- 11
- Pages
- 10
- FEI number
- 3010536120
In short: On April 9, 2020, FDA issued a Form 483 with 11 observations to Medical Center Pharmacy, Inc. in Cleveland, Tennessee (FEI 3010536120) after an inspection that ran Mar 9 – Apr 9, 2020. The investigators were Demario L. Walls and June P. Page. 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 8 of 11 observations.
Most cited: 21 CFR 211.42 (4×) · 211.113 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Sources of non-microbial contamination were observed in the ISO 5 classified aseptic processing areas that are…
- 02
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing…
- 03
You did not make adequate product evaluation and take remedial action where microbial contamination was found…
- 04
Your aseptic processing conditions do not offer sufficient assurance that the finished product will meet an…
This inspection in context
Demario L. Walls
18 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmMedical Center Pharmacy, Inc. history
All 3 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 Medical Center Pharmacy, Inc.?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 Medical Center Pharmacy, Inc.?
Demario L. Walls and June P. Page are named on this Form 483, for the inspection of Mar 9 – Apr 9, 2020. Each investigator has a profile showing what they cite most.
When was Medical Center Pharmacy, Inc. inspected by FDA?
The inspection ran Mar 9 – Apr 9, 2020, and the Form 483 is dated April 9, 2020.
How do I get the full Form 483 for Medical Center 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.