Family Pharmacy of Statesville
Form 483 issued February 12, 2020 · Statesville, North Carolina
- Inspection
- Feb 3 – Feb 12, 2020
- Investigator
- Joanne E. King
- Observations
- 9
- Pages
- 5
- FEI number
- 3015859129
In short: On February 12, 2020, FDA issued a Form 483 with 9 observations to Family Pharmacy of Statesville in Statesville, North Carolina (FEI 3015859129) after an inspection that ran Feb 3 – Feb 12, 2020. The investigator was Joanne E. King. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 6 of 9 observations.
Most cited: 21 CFR 211.113 (3×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Sporicidal agents were not used in your facility's cleanrooms and/or ISO 5…
- 02
You have no assurance that the endotoxin level of your intrathecal drug products is safe, since…
- 03
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing…
- 04
Your facility design allowed the influx of poor quality air into…
This inspection in context
Joanne E. King
34 documents · 2013–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmFamily Pharmacy of Statesville 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 Family Pharmacy of Statesville?
FDA listed 9 observations on this Form 483, mostly about production, laboratory controls 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 Family Pharmacy of Statesville?
Joanne E. King is named on this Form 483, for the inspection of Feb 3 – Feb 12, 2020. Each investigator has a profile showing what they cite most.
When was Family Pharmacy of Statesville inspected by FDA?
The inspection ran Feb 3 – Feb 12, 2020, and the Form 483 is dated February 12, 2020.
How do I get the full Form 483 for Family Pharmacy of Statesville?
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.