Milbar Laboratories, Inc.
Form 483 issued December 27, 2017 · East Haven, Connecticut
- Inspection
- Dec 7 – Dec 27, 2017
- Investigator
- Nealie C. Newberger
- Observations
- 1
- Pages
- 9
- FEI number
- 2835254
In short: On December 27, 2017, FDA issued a Form 483 with 1 observation to Milbar Laboratories, Inc. in East Haven, Connecticut (FEI 2835254) after an inspection that ran Dec 7 – Dec 27, 2017. The investigator was Nealie C. Newberger. Most observations concern materials; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.80 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There was a failure to handle and store components at all times in a manner to…
This inspection in context
Nealie C. Newberger
9 documents · 2016–2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Connecticut.
The firmMilbar Laboratories, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Milbar Laboratories, Inc.?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Milbar Laboratories, Inc.?
Nealie C. Newberger is named on this Form 483, for the inspection of Dec 7 – Dec 27, 2017. Each investigator has a profile showing what they cite most.
When was Milbar Laboratories, Inc. inspected by FDA?
The inspection ran Dec 7 – Dec 27, 2017, and the Form 483 is dated December 27, 2017.
How do I get the full Form 483 for Milbar Laboratories, 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.