Spoonamore Drug Co Inc.
Form 483 issued February 3, 2015 · Louisville, Kentucky
- Inspection
- Jan 13 – Feb 3, 2015
- Investigator
- Kathleen Dt Culver
- Observations
- 7
- Pages
- 3
- FEI number
- 3005472652
In short: On February 3, 2015, FDA issued a Form 483 with 7 observations to Spoonamore Drug Co Inc. in Louisville, Kentucky (FEI 3005472652) after an inspection that ran Jan 13 – Feb 3, 2015. The investigator was Kathleen Dt Culver. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system for…
- 02
An adequate number of batches of each drug product are not tested to determine…
- 03
Each batch of drug product purporting to be sterile is not laboratory tested to determine…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Kathleen Dt Culver
2 documents · 2014–2015
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
The firmSpoonamore Drug Co Inc. history
All 4 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 Spoonamore Drug Co Inc.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Spoonamore Drug Co Inc.?
Kathleen Dt Culver is named on this Form 483, for the inspection of Jan 13 – Feb 3, 2015. Each investigator has a profile showing what they cite most.
When was Spoonamore Drug Co Inc. inspected by FDA?
The inspection ran Jan 13 – Feb 3, 2015, and the Form 483 is dated February 3, 2015.
How do I get the full Form 483 for Spoonamore Drug Co 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.