The Compounding Pharmacy of America
Form 483 issued February 21, 2018 · Knoxville, Tennessee
- Inspection
- Jan 26 – Feb 1, 2018
- Investigator
- Brandon C. Heitmeier
- Observations
- 2
- Pages
- 1
- FEI number
- 3011504027
In short: On February 21, 2018, FDA issued a Form 483 with 2 observations to The Compounding Pharmacy of America in Knoxville, Tennessee (FEI 3011504027) after an inspection that ran Jan 26 – Feb 1, 2018. The investigator was Brandon C. Heitmeier. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
- 02
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or…
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 firmThe Compounding Pharmacy of America history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The Compounding Pharmacy of America?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. 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 The Compounding Pharmacy of America?
Brandon C. Heitmeier is named on this Form 483, for the inspection of Jan 26 – Feb 1, 2018. Each investigator has a profile showing what they cite most.
When was The Compounding Pharmacy of America inspected by FDA?
The inspection ran Jan 26 – Feb 1, 2018, and the Form 483 is dated February 21, 2018.
How do I get the full Form 483 for The Compounding Pharmacy of America?
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.