Medical Center Pharmacy, Inc.
Form 483 issued October 13, 2015 · Cleveland, Tennessee
- Inspection
- Sep 28 – Oct 13, 2015
- Investigator
- Brandon C. Heitmeier
- Observations
- 14
- Pages
- 8
- FEI number
- 3010536120
In short: On October 13, 2015, FDA issued a Form 483 with 14 observations to Medical Center Pharmacy, Inc. in Cleveland, Tennessee (FEI 3010536120) after an inspection that ran Sep 28 – Oct 13, 2015. The investigator was Brandon C. Heitmeier. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Laboratory controls and facilities & equipment account for 11 of 14 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Clothing of personnel engaged in the manufacturing, processing, and packing of drug products is not appropriate…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 04
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
This inspection in context
Brandon C. Heitmeier
12 documents · 2009–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Tennessee.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medical Center Pharmacy, Inc.?
FDA listed 14 observations on this Form 483, mostly about laboratory controls, 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 Medical Center Pharmacy, Inc.?
Brandon C. Heitmeier is named on this Form 483, for the inspection of Sep 28 – Oct 13, 2015. Each investigator has a profile showing what they cite most.
When was Medical Center Pharmacy, Inc. inspected by FDA?
The inspection ran Sep 28 – Oct 13, 2015, and the Form 483 is dated October 13, 2015.
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.