Milbar Laboratories, Inc.
Form 483 issued December 27, 2017 · East Haven, Connecticut
- Inspection
- Dec 7 – Dec 27, 2017
- Investigator
- Nealie C. Newberger
- Observations
- 8
- Pages
- 9
- FEI number
- 2435254
In short: On December 27, 2017, FDA issued a Form 483 with 8 observations to Milbar Laboratories, Inc. in East Haven, Connecticut (FEI 2435254) after an inspection that ran Dec 7 – Dec 27, 2017. The investigator was Nealie C. Newberger. Most observations concern quality system and production.
At a glance
Quality system and production account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
There was a failure to handle and store components at all times in a manner to…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
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
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.80(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Milbar Laboratories, Inc.?
FDA listed 8 observations on this Form 483, mostly about quality system, production and materials. 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.