Spoonamore Drug Co Inc.
FDA inspection history in Louisville, Kentucky, 2015 to 2018
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2015: one warning letter and one Form 483; 2017: one Form 483; 2018: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–18Two Form 483s, one warning letter and one close-out letter, at Louisville, Kentucky.
- 2015The longest 483 on file: 7 observations over 3 pages at Louisville, Kentucky.
Cited most
Across all Spoonamore Drug Co observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.166Stability testing1
- 21 CFR 211.167Special testing requirements1
The complete Spoonamore Drug Co file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Louisville, Kentucky
Two Form 483s, one close-out letter and one warning letter · 2015 to 2018 · 10 observations
Latest: Close-out, May 17, 2018 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-05-17 | Close-out Close-out letter | Louisville, Kentucky | — | $99 |
| 2017-01-17 | 483 Form 483 | Louisville, Kentucky | 3 | $99 |
| 2015-12-18 | Warning letter Warning letter | Louisville, Kentucky | — | $99 |
| 2015-02-03 | 483 Form 483 | Louisville, Kentucky | 7 | $99 |
Investigators on these documents
FEI number 3005472652 · most recent document May 17, 2018
About Spoonamore Drug Co Inc.
How many FDA Form 483s has Spoonamore Drug Co Inc. received?
FDA Intel has 2 Form 483s on file for Spoonamore Drug Co Inc.; the most recent is dated Jan 17, 2017.
When was Spoonamore Drug Co Inc. last inspected by FDA?
The most recent FDA inspection document on file for Spoonamore Drug Co Inc. is a Form 483 dated Jan 17, 2017, for the site in Louisville, Kentucky.
What did FDA cite at Spoonamore Drug Co Inc.?
The regulations cited most in the observations on file for Spoonamore Drug Co Inc. are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.165 (Testing and release for distribution), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.
Has Spoonamore Drug Co Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Spoonamore Drug Co Inc.; the most recent is dated Dec 18, 2015.