Gipsco Investment Corp. dba Lee Silsby Compounding Pharmacy
FDA inspection history across 2 sites, 2017 to 2023
- 2
- Close-outs
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2017: one Form 483; 2018: one close-out letter; 2023: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–18One Form 483 and one close-out letter, at Cleveland Heights, Ohio.
- 2023One close-out letter, at Beachwood, Ohio.
Cited most
Across all Gipsco Investment Corp. dba Lee Silsby Compounding Pharmacy observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.28Personnel responsibilities2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.46Ventilation, air filtration, air heating and cooling1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Gipsco Investment Corp. dba Lee Silsby Compounding Pharmacy file.
All 3 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
Cleveland Heights, Ohio
One close-out letter and one Form 483 · 2017 to 2018 · 9 observations
Latest: Close-out, Jul 10, 2018 →Beachwood, Ohio
One close-out letter · 2023
Latest: Close-out, Jan 5, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-01-05 | Close-out Close-out letter | Beachwood, Ohio | — | $99 |
| 2018-07-10 | Close-out Close-out letter | Cleveland Heights, Ohio | — | $99 |
| 2017-06-09 | 483 Form 483 | Cleveland Heights, Ohio | 9 | $99 |
Investigators on these documents
FEI number 3005457901 · most recent document Jan 5, 2023
About Gipsco Investment Corp. dba Lee Silsby Compounding Pharmacy
How many FDA Form 483s has Gipsco Investment Corp. dba Lee Silsby Compounding Pharmacy received?
FDA Intel has 1 Form 483 on file for Gipsco Investment Corp. dba Lee Silsby Compounding Pharmacy; the most recent is dated Jun 9, 2017.
When was Gipsco Investment Corp. dba Lee Silsby Compounding Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for Gipsco Investment Corp. dba Lee Silsby Compounding Pharmacy is a Form 483 dated Jun 9, 2017, for the site in Cleveland Heights, Ohio.
What did FDA cite at Gipsco Investment Corp. dba Lee Silsby Compounding Pharmacy?
The regulations cited most in the observations on file for Gipsco Investment Corp. dba Lee Silsby Compounding Pharmacy are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.28 (Personnel responsibilities), 2 times; 21 CFR 211.42 (Design and construction features), 2 times.