Front Door Pharmacy, LLC dba Pure
Form 483 issued March 18, 2019 · Houston, Texas
- Inspection
- Feb 25 – Mar 18, 2019
- Investigator
- Camerson E. Moore
- Observations
- 11
- Pages
- 5
- FEI number
- 3012937475
In short: On March 18, 2019, FDA issued a Form 483 with 11 observations to Front Door Pharmacy, LLC dba Pure in Houston, Texas (FEI 3012937475) after an inspection that ran Feb 25 – Mar 18, 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 11 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (7×) · 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
Personnel engaged in aseptic processing were…
- 02
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Equipment and materials or supplies were no disinfected prior to entering…
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 firmFront Door Pharmacy, LLC dba Pure 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 Front Door Pharmacy, LLC dba Pure?
FDA listed 11 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 Front Door Pharmacy, LLC dba Pure?
Camerson E. Moore is named on this Form 483, for the inspection of Feb 25 – Mar 18, 2019. Each investigator has a profile showing what they cite most.
When was Front Door Pharmacy, LLC dba Pure inspected by FDA?
The inspection ran Feb 25 – Mar 18, 2019, and the Form 483 is dated March 18, 2019.
How do I get the full Form 483 for Front Door Pharmacy, LLC dba Pure?
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.