Family Pharmacy of Statesville
Form 483 issued March 11, 2022 · Statesville, North Carolina
- Inspection
- Mar 7 – Mar 11, 2022
- Investigators
- Song Y. Lavalais· Sonya M. Edmonds
- Observations
- 9
- Pages
- 5
- FEI number
- 3015859129
In short: On March 11, 2022, FDA issued a Form 483 with 9 observations to Family Pharmacy of Statesville in Statesville, North Carolina (FEI 3015859129) after an inspection that ran Mar 7 – Mar 11, 2022. The investigators were Song Y. Lavalais and Sonya M. Edmonds. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and production account for 9 of 9 observations.
Most cited: 21 CFR 211.113 (4×) · 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your facility was operated in a way that pennits…
- 02
Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were…
- 03
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
- 04
You did not have a HEPA filter over the area to which sterile product was exposed…
This inspection in context
Song Y. Lavalais
5 documents · 2021–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Georgia.
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 facilities & equipment and production. 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?
Song Y. Lavalais and Sonya M. Edmonds are named on this Form 483, for the inspection of Mar 7 – Mar 11, 2022. Each investigator has a profile showing what they cite most.
When was Family Pharmacy of Statesville inspected by FDA?
The inspection ran Mar 7 – Mar 11, 2022, and the Form 483 is dated March 11, 2022.
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.