Gcncntcch Inc
Form 483 issued August 28, 2015 · Vacaville, California
- Inspection
- Aug 17 – Aug 28, 2015
- Investigators
- David Eng· Ileana Barreto-Pettit· Rebeca Rodriguez
- Observations
- 2
- Pages
- 2
- FEI number
- 3002902534
In short: On August 28, 2015, FDA issued a Form 483 with 2 observations to Gcncntcch Inc in Vacaville, California (FEI 3002902534) after an inspection that ran Aug 17 – Aug 28, 2015. The investigators were David Eng, Ileana Barreto-Pettit and Rebeca Rodriguez. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
Facilities & equipment and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.63 (1×) · 211.80 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to have equipment used in the manufacture of drug substances that are of appropriate design…
- 02
Written procedures are not followed for the handling, sampling, approval…
This inspection in context
David Eng
5 documents · 2015–2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmGcncntcch Inc 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 Gcncntcch Inc?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected Gcncntcch Inc?
David Eng, Ileana Barreto-Pettit and Rebeca Rodriguez are named on this Form 483, for the inspection of Aug 17 – Aug 28, 2015. Each investigator has a profile showing what they cite most.
When was Gcncntcch Inc inspected by FDA?
The inspection ran Aug 17 – Aug 28, 2015, and the Form 483 is dated August 28, 2015.
How do I get the full Form 483 for Gcncntcch Inc?
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