Milbar Laboratories, Inc.
Form 483 issued September 27, 2022 · East Haven, Connecticut
- Inspection
- Sep 6 – Sep 27, 2022
- Investigator
- Robert J. Martin
- Observations
- 13
- Pages
- 12
- FEI number
- 2435254
In short: On September 27, 2022, FDA issued a Form 483 with 13 observations to Milbar Laboratories, Inc. in East Haven, Connecticut (FEI 2435254) after an inspection that ran Sep 6 – Sep 27, 2022. The investigator was Robert J. Martin. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and laboratory controls account for 9 of 13 observations.
Most cited: 21 CFR 211.100(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 03
The written stability testing…
- 04
The written stability program for drug products does not include reliable, meaningful…
This inspection in context
Robert J. Martin
29 documents · 2014–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Milbar Laboratories, Inc.?
FDA listed 13 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Milbar Laboratories, Inc.?
Robert J. Martin is named on this Form 483, for the inspection of Sep 6 – Sep 27, 2022. Each investigator has a profile showing what they cite most.
When was Milbar Laboratories, Inc. inspected by FDA?
The inspection ran Sep 6 – Sep 27, 2022, and the Form 483 is dated September 27, 2022.
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.