C. O. Truxton Inc
Form 483 issued June 1, 2017 · Bellmawr, New Jersey
- Inspection
- Apr 17 – Jun 1, 2017
- Investigator
- Nancy M. Espinal
- Observations
- 11
- Pages
- 6
- FEI number
- 2220338
In short: On June 1, 2017, FDA issued a Form 483 with 11 observations to C. O. Truxton Inc in Bellmawr, New Jersey (FEI 2220338) after an inspection that ran Apr 17 – Jun 1, 2017. The investigator was Nancy M. Espinal. Most observations concern quality system and packaging & labeling.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no quality…
- 02
GMP training is not conducted to assure that employees remain familiar with CGMP…
- 03
Procedures describing the handling of written and oral complaints related to drug products are…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Nancy M. Espinal
16 documents · 2016–2022
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmC. O. Truxton Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at C. O. Truxton Inc?
FDA listed 11 observations on this Form 483, mostly about quality system, packaging & labeling and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected C. O. Truxton Inc?
Nancy M. Espinal is named on this Form 483, for the inspection of Apr 17 – Jun 1, 2017. Each investigator has a profile showing what they cite most.
When was C. O. Truxton Inc inspected by FDA?
The inspection ran Apr 17 – Jun 1, 2017, and the Form 483 is dated June 1, 2017.
How do I get the full Form 483 for C. O. Truxton 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.