Telix IsoTherapeutics Group, Inc.
Form 483 issued May 17, 2019 · Angleton, Texas
- Investigator
- Camerson E. Moore
- Observations
- 5
- Pages
- 5
- FEI number
- 3007294884
In short: On May 17, 2019, FDA issued a Form 483 with 5 observations to Telix IsoTherapeutics Group, Inc. in Angleton, Texas (FEI 3007294884). The investigator was Camerson E. Moore. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 02
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Procedures describing the handling of written and oral complaints related to drug products are…
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 firmTelix IsoTherapeutics Group, Inc. history
The site's inspection history, in date order.
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 Telix IsoTherapeutics Group, Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Telix IsoTherapeutics Group, Inc.?
Camerson E. Moore is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Telix IsoTherapeutics Group, Inc. inspected by FDA?
This Form 483 is dated May 17, 2019.
How do I get the full Form 483 for Telix IsoTherapeutics Group, Inc.?
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.