Mallinckrodt Inc
Form 483 issued January 17, 2025 · Hobart, New York
- Inspection
- Jan 6 – Jan 17, 2025
- Investigators
- Armen H. Youssoufian· Lori M. Newman
- Observations
- 4
- Pages
- 7
- FEI number
- 1317295
In short: On January 17, 2025, FDA issued a Form 483 with 4 observations to Mallinckrodt Inc in Hobart, New York (FEI 1317295) after an inspection that ran Jan 6 – Jan 17, 2025. The investigators were Armen H. Youssoufian and Lori M. Newman. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 3 of 4 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 02
Established laboratory control mechanisms…
- 03
Equipment for adequate control over air pressure is not provided when appropriate for the manufacture, processing…
- 04
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Armen H. Youssoufian
9 documents · 2023–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmMallinckrodt Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mallinckrodt Inc?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Mallinckrodt Inc?
Armen H. Youssoufian and Lori M. Newman are named on this Form 483, for the inspection of Jan 6 – Jan 17, 2025. Each investigator has a profile showing what they cite most.
When was Mallinckrodt Inc inspected by FDA?
The inspection ran Jan 6 – Jan 17, 2025, and the Form 483 is dated January 17, 2025.
How do I get the full Form 483 for Mallinckrodt 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.