West Coast Nuclear Pharmacy, LLC
Form 483 issued March 23, 2018 · Tampa, Florida
- Inspection
- Mar 19 – Mar 23, 2018
- Investigator
- Joanne E. King
- Observations
- 7
- Pages
- 3
- FEI number
- 3010421557
In short: On March 23, 2018, FDA issued a Form 483 with 7 observations to West Coast Nuclear Pharmacy, LLC in Tampa, Florida (FEI 3010421557) after an inspection that ran Mar 19 – Mar 23, 2018. The investigator was Joanne E. King. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
5 of 7 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (5×) · 211.42 (1×)
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
Poor aseptic practices were…
- 03
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
- 04
The facility design was observed to allow the influx of poor quality air into a…
This inspection in context
Joanne E. King
34 documents · 2013–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmWest Coast Nuclear Pharmacy, LLC 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 West Coast Nuclear Pharmacy, LLC?
FDA listed 7 observations on this Form 483, mostly about production and facilities & equipment. 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 West Coast Nuclear Pharmacy, LLC?
Joanne E. King is named on this Form 483, for the inspection of Mar 19 – Mar 23, 2018. Each investigator has a profile showing what they cite most.
When was West Coast Nuclear Pharmacy, LLC inspected by FDA?
The inspection ran Mar 19 – Mar 23, 2018, and the Form 483 is dated March 23, 2018.
How do I get the full Form 483 for West Coast Nuclear Pharmacy, LLC?
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.