Front Door Pharmacy, LLC dba Pure
Form 483 issued June 7, 2021 · Houston, Texas
- Inspection
- May 11 – Jun 7, 2021
- Investigator
- Camerson E. Moore
- Observations
- 7
- Pages
- 4
- FEI number
- 3012937475
In short: On June 7, 2021, FDA issued a Form 483 with 7 observations to Front Door Pharmacy, LLC dba Pure in Houston, Texas (FEI 3012937475) after an inspection that ran May 11 – Jun 7, 2021. The investigator was Camerson E. Moore. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 7 of 7 observations.
Most cited: 21 CFR 211.42 (5×) · 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel were observed conducting aseptic manipulations or placing equipment/supplies in an area that blocked the movement…
- 02
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
- 03
High Risk Media Fill Test fail to represent actual aseptic production practices, which include the stopper…
- 04
The use of sporicidal agents in the cleanrooms and ISO 5 classified aseptic…
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 211.42
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 7 observations on this Form 483, mostly about 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 Front Door Pharmacy, LLC dba Pure?
Camerson E. Moore is named on this Form 483, for the inspection of May 11 – Jun 7, 2021. Each investigator has a profile showing what they cite most.
When was Front Door Pharmacy, LLC dba Pure inspected by FDA?
The inspection ran May 11 – Jun 7, 2021, and the Form 483 is dated June 7, 2021.
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.