Maitland Labs of Central Florida
Form 483 issued June 17, 2019 · Orlando, Florida
- Inspection
- Jun 4 – Jun 17, 2019
- Investigator
- Jessica L. Pressley
- Observations
- 9
- Pages
- 5
- FEI number
- 3013854204
In short: On June 17, 2019, FDA issued a Form 483 with 9 observations to Maitland Labs of Central Florida in Orlando, Florida (FEI 3013854204) after an inspection that ran Jun 4 – Jun 17, 2019. The investigator was Jessica L. Pressley. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 6 of 9 observations.
Most cited: FDCA 503B(a)(10) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system for cleaning an d disinfecting the room and…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
This inspection in context
Jessica L. Pressley
24 documents · 2014–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Florida.
The firmMaitland Labs of Central Florida history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(v)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Maitland Labs of Central Florida?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. 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 Maitland Labs of Central Florida?
Jessica L. Pressley is named on this Form 483, for the inspection of Jun 4 – Jun 17, 2019. Each investigator has a profile showing what they cite most.
When was Maitland Labs of Central Florida inspected by FDA?
The inspection ran Jun 4 – Jun 17, 2019, and the Form 483 is dated June 17, 2019.
How do I get the full Form 483 for Maitland Labs of Central Florida?
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.