James K. Ireland
FDA investigator
Appears on 10 documents from 2016 to 2019, mostly at sites in Minnesota. Most often cites control of microbiological contamination (21 CFR 211.113).
- 10
- Documents on file
- 4.6
- Observations per 483
- 2016
- First seen
- 2019
- Most recent
What they cite most
From 46 observations- 21 CFR 211.113Control of microbiological contamination7
- 21 CFR 211.22Responsibilities of quality control unit5
- 21 CFR 211.165Testing and release for distribution4
- 21 CFR 211.166(a)Stability testing3
- 21 CFR 211.192Production record review3
- 21 CFR 211.67Equipment cleaning and maintenance3
Activity by year
2016: 1, 2017: 1, 2018: 5, 2019: 3
Where
Minnesota 6 · Wisconsin 2 · Illinois 1 · Michigan 1
Often inspects with
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Inspection history
10 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-10-10 | 483 Techni Med, Inc. dba The CompounderOct 10, 2019 · Aurora, Illinois | Aurora, Illinois | 5 | |
| 2019-07-25 | 483 Radix Laboratories IncJul 25, 2019 · Eau Claire, Wisconsin | Eau Claire, Wisconsin | 3 | |
| 2019-01-31 | 483 LTS Therapy Systems, LLCJan 31, 2019 · West St. Paul, Minnesota | West St. Paul, Minnesota | 2 | |
| 2018-12-06 | 483 EPIEN Medical, Inc.Dec 6, 2018 · St. Paul, Minnesota | St. Paul, Minnesota | 3 | |
| 2018-09-28 | 483 SV Labs Prescott CorporationSep 28, 2018 · Prescott, Wisconsin | Prescott, Wisconsin | 15 | |
| 2018-09-21 | 483 Pharmacia & Upjohn Company LLCSep 21, 2018 · Kalamazoo, Michigan | Kalamazoo, Michigan | 3 | |
| 2018-08-15 | 483 Mayo Clinic PharmacyAug 15, 2018 · Rochester, Minnesota | Rochester, Minnesota | 5 |
About this profile
What does James K. Ireland inspect?
James K. Ireland appears on 10 documents on file covering 10 sites, mostly in Minnesota.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.22 and 21 CFR 211.165.
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for James K. Ireland is dated Oct 10, 2019.