Home Care Pharmacy of Palm Coast Inc.
Form 483 issued June 17, 2016 · Palm Coast, Florida
- Inspection
- May 25, 2016
- Investigator
- Shelby N. Marler
- Observations
- 7
- Pages
- 5
- FEI number
- 3006899675
In short: On June 17, 2016, FDA issued a Form 483 with 7 observations to Home Care Pharmacy of Palm Coast Inc. in Palm Coast, Florida (FEI 3006899675) after an inspection that ran May 25, 2016. The investigator was Shelby N. Marler. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for…
- 04
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
This inspection in context
Shelby N. Marler
10 documents · 2015–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmHome Care Pharmacy of Palm Coast Inc. 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(c)(10)(v)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Home Care Pharmacy of Palm Coast Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 Home Care Pharmacy of Palm Coast Inc.?
Shelby N. Marler is named on this Form 483, for the inspection of May 25, 2016. Each investigator has a profile showing what they cite most.
When was Home Care Pharmacy of Palm Coast Inc. inspected by FDA?
The inspection ran May 25, 2016, and the Form 483 is dated June 17, 2016.
How do I get the full Form 483 for Home Care Pharmacy of Palm Coast 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.