Universal Synergetics, Inc.
Form 483 issued September 13, 2016 · Marlton, New Jersey
- Inspection
- Aug 31 – Sep 13, 2016
- Investigators
- Devon Jenkins· Teigan M. Mule
- Observations
- 1
- Pages
- 1
- FEI number
- 3004816991
In short: On September 13, 2016, FDA issued a Form 483 with 1 observation to Universal Synergetics, Inc. in Marlton, New Jersey (FEI 3004816991) after an inspection that ran Aug 31 – Sep 13, 2016. The investigators were Devon Jenkins and Teigan M. Mule. Most observations concern dietary supplement CGMP; the most-cited regulation is 21 CFR 111.73 (what is your responsibility for determining whether established specifications are met?).
At a glance
1 of 1 observations on this 483 concern dietary supplement cgmp.
Most cited: 21 CFR 111.73 (1×)
What FDA observed
Preview: the opening words of each observation- 0121 CFR 111.73
You did not determine whether you met established product specifications for identity, purity, strength and composition…
This inspection in context
Devon Jenkins
1 document · 2016
Cites 111.73 (what is your responsibility for determining whether established specifications are met?) more than any other section. Most of their documents are for sites in New Jersey.
The firmUniversal Synergetics, Inc. history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Universal Synergetics, Inc.?
FDA listed 1 observation on this Form 483, mostly about dietary supplement CGMP. The most-cited regulation is 21 CFR 111.73 (what is your responsibility for determining whether established specifications are met?). The opening words of each observation are shown on this page.
Who inspected Universal Synergetics, Inc.?
Devon Jenkins and Teigan M. Mule are named on this Form 483, for the inspection of Aug 31 – Sep 13, 2016. Each investigator has a profile showing what they cite most.
When was Universal Synergetics, Inc. inspected by FDA?
The inspection ran Aug 31 – Sep 13, 2016, and the Form 483 is dated September 13, 2016.
How do I get the full Form 483 for Universal Synergetics, 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.