Tri-Coast Pharmacy, Inc.
Form 483 issued October 14, 2016 · Juno Beach, Florida
- Inspection
- Oct 14, 2016
- Investigators
- Jennifer L. Huntington· Jessica L. Pressley
- Observations
- 9
- Pages
- 5
- FEI number
- 3011827553
In short: On October 14, 2016, FDA issued a Form 483 with 9 observations to Tri-Coast Pharmacy, Inc. in Juno Beach, Florida (FEI 3011827553) after an inspection that ran Oct 14, 2016. The investigators were Jennifer L. Huntington and Jessica L. Pressley. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 8 of 9 observations.
Most cited: 21 CFR 211.113 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Actionable microbial contamination was present in the ISO 5 area or in adjacent areas during aseptic…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Personnel failed to disinfect or change gloves frequently…
- 04
There is no HEPA filter (laminar air flow) over the area to which…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmTri-Coast Pharmacy, Inc. history
All 2 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 Tri-Coast Pharmacy, Inc.?
FDA listed 9 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Tri-Coast Pharmacy, Inc.?
Jennifer L. Huntington and Jessica L. Pressley are named on this Form 483, for the inspection of Oct 14, 2016. Each investigator has a profile showing what they cite most.
When was Tri-Coast Pharmacy, Inc. inspected by FDA?
The inspection ran Oct 14, 2016, and the Form 483 is dated October 14, 2016.
How do I get the full Form 483 for Tri-Coast Pharmacy, 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.