BayCare Integrated Service Center
Form 483 issued March 12, 2026 · Temple Terrace, Florida
- Inspection
- Feb 17 – Mar 12, 2026
- Investigator
- Jose R. Lopez
- Observations
- 9
- Pages
- 10
- FEI number
- 3013023419
In short: On March 12, 2026, FDA issued a Form 483 with 9 observations to BayCare Integrated Service Center in Temple Terrace, Florida (FEI 3013023419) after an inspection that ran Feb 17 – Mar 12, 2026. The investigator was Jose R. Lopez. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Quality system and production account for 7 of 9 observations.
Most cited: 21 CFR 211.42 (2×) · 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
Laboratory records do not include the initials or signature of a second person showing that the…
This inspection in context
Jose R. Lopez
7 documents · 2010–2026
Cites 211.100 (written procedures; deviations) 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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BayCare Integrated Service Center?
FDA listed 9 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected BayCare Integrated Service Center?
Jose R. Lopez is named on this Form 483, for the inspection of Feb 17 – Mar 12, 2026. Each investigator has a profile showing what they cite most.
When was BayCare Integrated Service Center inspected by FDA?
The inspection ran Feb 17 – Mar 12, 2026, and the Form 483 is dated March 12, 2026.
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.