Nostrum Laboratories, Inc.
Form 483 issued March 13, 2025 · Bryan, Ohio
- Inspection
- Feb 28 – Mar 13, 2025
- Investigators
- Michael O. Idowu· Michael T. Cyrus
- Observations
- 3
- Pages
- 33
- FEI number
- 1518957
In short: On March 13, 2025, FDA issued a Form 483 with 3 observations to Nostrum Laboratories, Inc. in Bryan, Ohio (FEI 1518957) after an inspection that ran Feb 28 – Mar 13, 2025. The investigators were Michael O. Idowu and Michael T. Cyrus. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The separate or defined areas and control systems necessary to prevent contamination…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Michael O. Idowu
4 documents · 2024–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Maryland.
The firmNostrum Laboratories, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nostrum Laboratories, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Nostrum Laboratories, Inc.?
Michael O. Idowu and Michael T. Cyrus are named on this Form 483, for the inspection of Feb 28 – Mar 13, 2025. Each investigator has a profile showing what they cite most.
When was Nostrum Laboratories, Inc. inspected by FDA?
The inspection ran Feb 28 – Mar 13, 2025, and the Form 483 is dated March 13, 2025.
How do I get the full Form 483 for Nostrum 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.