Health Innovations Pharmacy, Inc.
Form 483 issued February 27, 2015 · Southern Pines, North Carolina
- Inspection
- Feb 23 – Feb 27, 2015
- Investigators
- Joseph F. Owens· Lareese K. Thomas
- Observations
- 10
- Pages
- 4
- FEI number
- 3011364861
In short: On February 27, 2015, FDA issued a Form 483 with 10 observations to Health Innovations Pharmacy, Inc. in Southern Pines, North Carolina (FEI 3011364861) after an inspection that ran Feb 23 – Feb 27, 2015. The investigators were Joseph F. Owens and Lareese K. Thomas. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Laboratory controls and facilities & equipment account for 7 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 03
Time limits are not established when appropriate for the completion of each production phase to assure…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
This inspection in context
Joseph F. Owens
2 documents · 2015
Cites 211.42(b) (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmHealth Innovations Pharmacy, Inc. history
All 2 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)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Health Innovations Pharmacy, Inc.?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, facilities & equipment 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 Health Innovations Pharmacy, Inc.?
Joseph F. Owens and Lareese K. Thomas are named on this Form 483, for the inspection of Feb 23 – Feb 27, 2015. Each investigator has a profile showing what they cite most.
When was Health Innovations Pharmacy, Inc. inspected by FDA?
The inspection ran Feb 23 – Feb 27, 2015, and the Form 483 is dated February 27, 2015.
How do I get the full Form 483 for Health Innovations Pharmacy, 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.