Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy
FDA inspection history in Fort Myers, Florida, 2014 to 2022
- 4
- Form 483s
Every document, by year
- Form 483
2014: one Form 483; 2017: one Form 483; 2020: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014One Form 483, at Fort Myers, Florida.
- 2014The longest 483 on file: 10 observations over 7 pages at Fort Myers, Florida.
- 2017One Form 483, at Fort Myers, Florida.
- 2020–22Two Form 483s, at Fort Myers, Florida.
Cited most
Across all Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy observations on file
- 21 CFR 211.113Control of microbiological contamination7
- 21 CFR 211.42(b)Design and construction features4
- 21 CFR 211.111Time limitations on production2
- 21 CFR 211.137(a)Expiration dating2
- 21 CFR 211.165(a)Testing and release for distribution2
The complete Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy 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
Fort Myers, Florida
Four Form 483s · 2014 to 2022 · 24 observations
Latest: Form 483, Aug 9, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-08-09 | 483 Form 483 | Fort Myers, Florida | 2 | $99 |
| 2020-02-09 | 483 Form 483 | Fort Myers, Florida | 3 | $99 |
| 2017-07-20 | 483 Form 483 | Fort Myers, Florida | 9 | $99 |
| 2014-12-22 | 483 Form 483 | Fort Myers, Florida | 10 | $99 |
Investigators on these documents
Jennifer Lalama (2)Jennifer L. Huntington (1)June P. Page (1)Michael H. Tollon (1)Saundrea A. Munroe (1)Steven A. Brettler (1)
FEI number 3011123993 · most recent document Aug 9, 2022
About Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy
How many FDA Form 483s has Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy received?
FDA Intel has 4 Form 483s on file for Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy; the most recent is dated Aug 9, 2022.
When was Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy is a Form 483 dated Aug 9, 2022, for the site in Fort Myers, Florida.
What did FDA cite at Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy?
The regulations cited most in the observations on file for Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy are 21 CFR 211.113 (Control of microbiological contamination), 7 times; 21 CFR 211.42(b) (Design and construction features), 4 times; 21 CFR 211.111 (Time limitations on production), 2 times.