Milbar Laboratories, Inc.
Form 483 issued November 7, 2024 · East Haven, Connecticut
- Inspection
- Oct 9 – Nov 7, 2024
- Observations
- 7
- Pages
- 6
- FEI number
- 2435254
In short: On November 7, 2024, FDA issued a Form 483 with 7 observations to Milbar Laboratories, Inc. in East Haven, Connecticut (FEI 2435254) after an inspection that ran Oct 9 – Nov 7, 2024. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Facilities & equipment and laboratory controls account for 5 of 7 observations.
Most cited: 21 CFR 211.166(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Results of stability testing are not used…
- 02
The written stability testing…
- 03
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination…
- 04
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
This inspection in context
Questions about this 483
What did FDA find at Milbar Laboratories, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, laboratory controls and materials. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
When was Milbar Laboratories, Inc. inspected by FDA?
The inspection ran Oct 9 – Nov 7, 2024, and the Form 483 is dated November 7, 2024.
How do I get the full Form 483 for Milbar Laboratories, Inc.?
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