Mallinckrodt Inc
FDA inspection history in Hobart, New York, 2016 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Hobart, New York.
- 2025One Form 483, at Hobart, New York.
- 2025The longest 483 on file: 4 observations over 7 pages at Hobart, New York.
Cited most
Across all Mallinckrodt observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.142(b)Warehousing procedures1
- 21 CFR 211.188(a)Batch production and control records1
- 21 CFR 211.46Ventilation, air filtration, air heating and cooling1
The complete Mallinckrodt file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Hobart, New York
Two Form 483s · 2016 to 2025 · 6 observations
Latest: Form 483, Jan 17, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-01-17 | 483 Form 483 | Hobart, New York | 4 | $99 |
| 2016-01-29 | 483 Form 483 | Hobart, New York | 2 | $99 |
Investigators on these documents
Armen H. Youssoufian (1)Lori M. Newman (1)Samina S. Khan (1)
FEI number 1317295 · most recent document Jan 17, 2025
About Mallinckrodt Inc
How many FDA Form 483s has Mallinckrodt Inc received?
FDA Intel has 2 Form 483s on file for Mallinckrodt Inc; the most recent is dated Jan 17, 2025.
When was Mallinckrodt Inc last inspected by FDA?
The most recent FDA inspection document on file for Mallinckrodt Inc is a Form 483 dated Jan 17, 2025, for the site in Hobart, New York.
What did FDA cite at Mallinckrodt Inc?
The regulations cited most in the observations on file for Mallinckrodt Inc are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.142(b) (Warehousing procedures), 1 time.