Spoonamore Drug Co Inc.
Form 483 issued January 17, 2017 · Louisville, Kentucky
- Inspection
- Jan 17, 2017
- Investigator
- Michael P. Sheehan
- Observations
- 3
- Pages
- 2
- FEI number
- 3005472652
In short: On January 17, 2017, FDA issued a Form 483 with 3 observations to Spoonamore Drug Co Inc. in Louisville, Kentucky (FEI 3005472652) after an inspection that ran Jan 17, 2017. The investigator was Michael P. Sheehan. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
EMPLOYEE(S) SIGNAlURE OATE ISSUEO Procedures for the cleaning and maintenance of equipment are deficient regarding inspection…
This inspection in context
Michael P. Sheehan
6 documents · 2011–2018
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 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Spoonamore Drug Co Inc.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Spoonamore Drug Co Inc.?
Michael P. Sheehan is named on this Form 483, for the inspection of Jan 17, 2017. Each investigator has a profile showing what they cite most.
When was Spoonamore Drug Co Inc. inspected by FDA?
The inspection ran Jan 17, 2017, and the Form 483 is dated January 17, 2017.
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.