Abilene Nuclear LLC dba National Central Pharmacy
Form 483 issued November 7, 2019 · Abilene, Texas
- Inspection
- Oct 28 – Nov 7, 2019
- Investigator
- Camerson E. Moore
- Observations
- 8
- Pages
- 4
- FEI number
- 3004819860
In short: On November 7, 2019, FDA issued a Form 483 with 8 observations to Abilene Nuclear LLC dba National Central Pharmacy in Abilene, Texas (FEI 3004819860) after an inspection that ran Oct 28 – Nov 7, 2019. The investigator was Camerson E. Moore. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
7 of 8 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (6×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel engaging in aseptic processing was…
- 02
Materials or supplies were not disinfected prior to entering…
- 03
Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area…
- 04
Personnel placed equipment/supplies in an area that blocked the movement of first pass air around an…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmAbilene Nuclear LLC dba National Central Pharmacy history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Abilene Nuclear LLC dba National Central Pharmacy?
FDA listed 8 observations on this Form 483, mostly about production 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 Abilene Nuclear LLC dba National Central Pharmacy?
Camerson E. Moore is named on this Form 483, for the inspection of Oct 28 – Nov 7, 2019. Each investigator has a profile showing what they cite most.
When was Abilene Nuclear LLC dba National Central Pharmacy inspected by FDA?
The inspection ran Oct 28 – Nov 7, 2019, and the Form 483 is dated November 7, 2019.
How do I get the full Form 483 for Abilene Nuclear LLC dba National Central 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.