HHCS Pharmacy, Inc. dba Freedom Pharmacy
Form 483 issued July 14, 2014 · Orlando, Florida
- Inspection
- Jul 14, 2014
- Investigators
- Carla A. Norris· Jessica L. Pressley
- Observations
- 8
- Pages
- 7
- FEI number
- 3004596923
In short: On July 14, 2014, FDA issued a Form 483 with 8 observations to HHCS Pharmacy, Inc. dba Freedom Pharmacy in Orlando, Florida (FEI 3004596923) after an inspection that ran Jul 14, 2014. The investigators were Carla A. Norris and Jessica L. Pressley. 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 6 of 8 observations.
Most cited: 21 CFR 211.42 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Clothing ofpersonnel engaged in the manufacturing and processing of drug products is not appropriate for…
This inspection in context
Carla A. Norris
3 documents · 2013–2014
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmHHCS Pharmacy, Inc. dba Freedom 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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at HHCS Pharmacy, Inc. dba Freedom Pharmacy?
FDA listed 8 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 HHCS Pharmacy, Inc. dba Freedom Pharmacy?
Carla A. Norris and Jessica L. Pressley are named on this Form 483, for the inspection of Jul 14, 2014. Each investigator has a profile showing what they cite most.
When was HHCS Pharmacy, Inc. dba Freedom Pharmacy inspected by FDA?
The inspection ran Jul 14, 2014, and the Form 483 is dated July 14, 2014.
How do I get the full Form 483 for HHCS Pharmacy, Inc. dba Freedom 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.