Garda Rx LLC
Form 483 issued June 6, 2017 · Apollo, Pennsylvania
- Inspection
- Jun 1 – Jun 6, 2017
- Investigator
- Juan R. Jimenez Garcia
- Observations
- 2
- Pages
- 1
- FEI number
- 3010375341
In short: On June 6, 2017, FDA issued a Form 483 with 2 observations to Garda Rx LLC in Apollo, Pennsylvania (FEI 3010375341) after an inspection that ran Jun 1 – Jun 6, 2017. The investigator was Juan R. Jimenez Garcia. Most observations concern facilities & equipment.
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The(b) (4) counter top used for the production of non-sterile drug products had exposed particle board…
- 02
Visible residues and filth adjacent to the non-sterile production area…
This inspection in context
Juan R. Jimenez Garcia
1 document · 2017
Cites 211.56 (sanitation) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmGarda Rx LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Garda Rx LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Garda Rx LLC?
Juan R. Jimenez Garcia is named on this Form 483, for the inspection of Jun 1 – Jun 6, 2017. Each investigator has a profile showing what they cite most.
When was Garda Rx LLC inspected by FDA?
The inspection ran Jun 1 – Jun 6, 2017, and the Form 483 is dated June 6, 2017.
How do I get the full Form 483 for Garda Rx LLC?
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.