BayCare Integrated Service Center
Form 483 issued December 10, 2019 · Temple Terrace, Florida
- Inspection
- Nov 18 – Dec 10, 2019
- Investigator
- Joanne E. King
- Observations
- 5
- Pages
- 5
- FEI number
- 3013023419
In short: On December 10, 2019, FDA issued a Form 483 with 5 observations to BayCare Integrated Service Center in Temple Terrace, Florida (FEI 3013023419) after an inspection that ran Nov 18 – Dec 10, 2019. The investigator was Joanne E. King. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The quality control unit lacks responsibility to approve and reject all procedmes or specifications impacting on…
- 03
The responsibilities and procedmes applicable to the quality control unit…
- 04FDCA 501(a)(2)(A)
Disinfectant contact time (also known as ) and coverage of the item being disinfected were insufficient…
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 firmBayCare Integrated Service Center history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BayCare Integrated Service Center?
FDA listed 5 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected BayCare Integrated Service Center?
Joanne E. King is named on this Form 483, for the inspection of Nov 18 – Dec 10, 2019. Each investigator has a profile showing what they cite most.
When was BayCare Integrated Service Center inspected by FDA?
The inspection ran Nov 18 – Dec 10, 2019, and the Form 483 is dated December 10, 2019.
How do I get the full Form 483 for BayCare Integrated Service Center?
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.