Compound Care Pharmacy
Form 483 issued May 16, 2019 · Louisville, Kentucky
- Inspection
- May 13 – May 16, 2019
- Investigator
- Adam R. Cooke
- Observations
- 2
- Pages
- 1
- FEI number
- 3006269306
In short: On May 16, 2019, FDA issued a Form 483 with 2 observations to Compound Care Pharmacy in Louisville, Kentucky (FEI 3006269306) after an inspection that ran May 13 – May 16, 2019. The investigator was Adam R. Cooke. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm released drug product in which the strength differs from, or its purity or quality…
- 02
Disinfecting agents and cleaning pacts or wipes used in the ISO 5…
This inspection in context
Adam R. Cooke
11 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmCompound Care Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Compound Care Pharmacy?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Compound Care Pharmacy?
Adam R. Cooke is named on this Form 483, for the inspection of May 13 – May 16, 2019. Each investigator has a profile showing what they cite most.
When was Compound Care Pharmacy inspected by FDA?
The inspection ran May 13 – May 16, 2019, and the Form 483 is dated May 16, 2019.
How do I get the full Form 483 for Compound Care Pharmacy?
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.