Medez Pharmacy of Polk Inc.
Form 483 issued August 9, 2019 · Davenport, Florida
- Inspection
- Jul 30 – Aug 9, 2019
- Investigator
- Jessica L. Pressley
- Observations
- 14
- Pages
- 7
- FEI number
- 3015316526
In short: On August 9, 2019, FDA issued a Form 483 with 14 observations to Medez Pharmacy of Polk Inc. in Davenport, Florida (FEI 3015316526) after an inspection that ran Jul 30 – Aug 9, 2019. The investigator was 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
Observations span 2 systems, led by production.
Most cited: FDCA 501(a)(2)(A) (9×) · 211.113 (3×)
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
You produced hazardous drugs without providing adequate cleaning of work surfaces and cleaning of personnel…
- 02FDCA 501(a)(2)(A)
Vermin was observed in…
- 03FDCA 501(a)(2)(A)
Venn in was observed in an area immediately adjacent…
- 04FDCA 501(a)(2)(A)
The ISO 5 classified aseptic processing areas had visibly…
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 firmMedez Pharmacy of Polk Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medez Pharmacy of Polk Inc.?
FDA listed 14 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 Medez Pharmacy of Polk Inc.?
Jessica L. Pressley is named on this Form 483, for the inspection of Jul 30 – Aug 9, 2019. Each investigator has a profile showing what they cite most.
When was Medez Pharmacy of Polk Inc. inspected by FDA?
The inspection ran Jul 30 – Aug 9, 2019, and the Form 483 is dated August 9, 2019.
How do I get the full Form 483 for Medez Pharmacy of Polk 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.