Mooney's Pharmacy, Inc.
Form 483 issued September 2, 2016 · Johnson City, Tennessee
- Inspection
- Aug 29 – Sep 2, 2016
- Investigator
- Brandon C. Heitmeier
- Observations
- 3
- Pages
- 2
- FEI number
- 3012066153
In short: On September 2, 2016, FDA issued a Form 483 with 3 observations to Mooney's Pharmacy, Inc. in Johnson City, Tennessee (FEI 3012066153) after an inspection that ran Aug 29 – Sep 2, 2016. The investigator was Brandon C. Heitmeier. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (3×) · 211.56 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Beta-lactam drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or…
- 02
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or…
- 03
The production areas have difficult to clean, particle-generating…
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 firmMooney's 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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mooney's Pharmacy, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. 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 Mooney's Pharmacy, Inc.?
Brandon C. Heitmeier is named on this Form 483, for the inspection of Aug 29 – Sep 2, 2016. Each investigator has a profile showing what they cite most.
When was Mooney's Pharmacy, Inc. inspected by FDA?
The inspection ran Aug 29 – Sep 2, 2016, and the Form 483 is dated September 2, 2016.
How do I get the full Form 483 for Mooney's 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.