Gipsco Investment Corp. dba Lee Silsby Compounding Pharmacy
Form 483 issued June 9, 2017 · Cleveland Heights, Ohio
- Inspection
- Jun 9, 2017
- Investigators
- Jazmine N. Still· Matthew B. Casale
- Observations
- 9
- Pages
- 3
- FEI number
- 3005457901
In short: On June 9, 2017, FDA issued a Form 483 with 9 observations to Gipsco Investment Corp. dba Lee Silsby Compounding Pharmacy in Cleveland Heights, Ohio (FEI 3005457901) after an inspection that ran Jun 9, 2017. The investigators were Jazmine N. Still and Matthew B. Casale. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.28 (personnel responsibilities).
At a glance
Production and facilities & equipment account for 7 of 9 observations.
Most cited: 21 CFR 211.113 (3×) · 211.28 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
we observed a gap, approximately~ inches, across the back of the HEPA screen in therof(4) Jlaminar…
- 02
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to…
- 03
There is no evidence that the(b} (4)preservative used to provideKI:>) (4~blanketing for glutathione ster;Je drug products…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Jazmine N. Still
16 documents · 2017–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmGipsco Investment Corp. dba Lee Silsby Compounding Pharmacy history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Gipsco Investment Corp. dba Lee Silsby Compounding Pharmacy?
FDA listed 9 observations on this Form 483, mostly about production, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.28 (personnel responsibilities). The opening words of each observation are shown on this page.
Who inspected Gipsco Investment Corp. dba Lee Silsby Compounding Pharmacy?
Jazmine N. Still and Matthew B. Casale are named on this Form 483, for the inspection of Jun 9, 2017. Each investigator has a profile showing what they cite most.
When was Gipsco Investment Corp. dba Lee Silsby Compounding Pharmacy inspected by FDA?
The inspection ran Jun 9, 2017, and the Form 483 is dated June 9, 2017.
How do I get the full Form 483 for Gipsco Investment Corp. dba Lee Silsby Compounding Pharmacy?
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.