Milbar Laboratories, Inc.
Form 483 issued October 11, 2019 · East Haven, Connecticut
- Inspection
- Sep 23 – Oct 11, 2019
- Investigator
- Adetutu Gidado
- Observations
- 11
- Pages
- 12
- FEI number
- 2435254
In short: On October 11, 2019, FDA issued a Form 483 with 11 observations to Milbar Laboratories, Inc. in East Haven, Connecticut (FEI 2435254) after an inspection that ran Sep 23 – Oct 11, 2019. The investigator was Adetutu Gidado. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 8 of 11 observations.
Most cited: 21 CFR 211.68 (3×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 02
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 03
Failure to maintain a backup file of data entered into the…
- 04
Routine calibration and inspection of mechanical and electronic equipment is not performed according to a written…
This inspection in context
Adetutu Gidado
16 documents · 2016–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Milbar Laboratories, Inc.?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Milbar Laboratories, Inc.?
Adetutu Gidado is named on this Form 483, for the inspection of Sep 23 – Oct 11, 2019. Each investigator has a profile showing what they cite most.
When was Milbar Laboratories, Inc. inspected by FDA?
The inspection ran Sep 23 – Oct 11, 2019, and the Form 483 is dated October 11, 2019.
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.