Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy
Form 483 issued August 31, 2016 · Pensacola, Florida
- Inspection
- Aug 22 – Aug 31, 2016
- Investigator
- Joshua P. Wireman
- Observations
- 5
- Pages
- 3
- FEI number
- 3005630265
In short: On August 31, 2016, FDA issued a Form 483 with 5 observations to Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy in Pensacola, Florida (FEI 3005630265) after an inspection that ran Aug 22 – Aug 31, 2016. The investigator was Joshua P. Wireman. Most observations concern production and facilities & equipment.
At a glance
3 of 4 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Employees are wearing gowning apparel improperly, in a way that may have caused the gowning…
- 02
Equipment, materials, and/or supplies are not disinfected prior to entering…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Joshua P. Wireman
8 documents · 2015–2019
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmPensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.28
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy?
FDA listed 5 observations on this Form 483, mostly about production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy?
Joshua P. Wireman is named on this Form 483, for the inspection of Aug 22 – Aug 31, 2016. Each investigator has a profile showing what they cite most.
When was Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy inspected by FDA?
The inspection ran Aug 22 – Aug 31, 2016, and the Form 483 is dated August 31, 2016.
How do I get the full Form 483 for Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy?
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.