Drug Crafters
Form 483 issued July 11, 2017 · Frisco, Texas
- Inspection
- Jul 2, 2018
- Investigator
- Jason R. Caballero
- Observations
- 2
- Pages
- 2
- FEI number
- 3010660340
In short: On July 11, 2017, FDA issued a Form 483 with 2 observations to Drug Crafters in Frisco, Texas (FEI 3010660340) after an inspection that ran Jul 2, 2018. The investigator was Jason R. Caballero. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×) · 211.28 (1×)
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 failed to…
- 02
Personnel engaged in aseptic processing were…
This inspection in context
Jason R. Caballero
26 documents · 2014–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmDrug Crafters 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 Drug Crafters?
FDA listed 2 observations on this Form 483, mostly about 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 Drug Crafters?
Jason R. Caballero is named on this Form 483, for the inspection of Jul 2, 2018. Each investigator has a profile showing what they cite most.
When was Drug Crafters inspected by FDA?
The inspection ran Jul 2, 2018, and the Form 483 is dated July 11, 2017.
How do I get the full Form 483 for Drug Crafters?
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.