George Tiemann & Co
Form 483 issued June 1, 2016 · Hauppauge, New York
- Inspection
- May 17 – Jun 1, 2016
- Investigators
- Christian Parra· Edouard Viard
- Observations
- 1
- Pages
- 2
- FEI number
- 2424531
In short: On June 1, 2016, FDA issued a Form 483 with 1 observation to George Tiemann & Co in Hauppauge, New York (FEI 2424531) after an inspection that ran May 17 – Jun 1, 2016. The investigators were Christian Parra and Edouard Viard. Most observations concern management controls; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
1 of 1 observations on this 483 concern management controls.
Most cited: 21 CFR 820.20(e) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Quality system procedures and instructions…
This inspection in context
Christian Parra
1 document · 2016
Cites 820.20(e) (management responsibility) more than any other section. Most of their documents are for sites in New York.
The firmGeorge Tiemann & Co history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at George Tiemann & Co?
FDA listed 1 observation on this Form 483, mostly about management controls. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
Who inspected George Tiemann & Co?
Christian Parra and Edouard Viard are named on this Form 483, for the inspection of May 17 – Jun 1, 2016. Each investigator has a profile showing what they cite most.
When was George Tiemann & Co inspected by FDA?
The inspection ran May 17 – Jun 1, 2016, and the Form 483 is dated June 1, 2016.
How do I get the full Form 483 for George Tiemann & Co?
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.