Mallinckrodt Inc
Form 483 issued January 29, 2016 · Hobart, New York
- Inspection
- Jan 26 – Jan 29, 2016
- Investigator
- Samina S. Khan
- Observations
- 2
- Pages
- 2
- FEI number
- 1317295
In short: On January 29, 2016, FDA issued a Form 483 with 2 observations to Mallinckrodt Inc in Hobart, New York (FEI 1317295) after an inspection that ran Jan 26 – Jan 29, 2016. The investigator was Samina S. Khan. Most observations concern materials and production; the most-cited regulation is 21 CFR 211.142 (warehousing procedures).
At a glance
Materials and production account for 2 of 2 observations.
Most cited: 21 CFR 211.142(b) (1×) · 211.188(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality…
- 02
Batch production and control records for each batch of drug product produced do not include an…
This inspection in context
Samina S. Khan
5 documents · 2015–2019
Cites 211.160 (general requirements) 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 211.142(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mallinckrodt Inc?
FDA listed 2 observations on this Form 483, mostly about materials and production. The most-cited regulation is 21 CFR 211.142 (warehousing procedures). The opening words of each observation are shown on this page.
Who inspected Mallinckrodt Inc?
Samina S. Khan is named on this Form 483, for the inspection of Jan 26 – Jan 29, 2016. Each investigator has a profile showing what they cite most.
When was Mallinckrodt Inc inspected by FDA?
The inspection ran Jan 26 – Jan 29, 2016, and the Form 483 is dated January 29, 2016.
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.