Johnna L. Bleem
FDA investigator
Appears on 6 documents from 2019 to 2021, mostly at sites in New York. Most often cites equipment cleaning and maintenance (21 CFR 211.67).
- 6
- Documents on file
- 3.8
- Observations per 483
- 2019
- First seen
- 2021
- Most recent
What they cite most
From 23 observations- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.192Production record review3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.28Personnel responsibilities2
- 21 CFR 211.42Design and construction features2
Activity by year
2019: 2, 2020: 1, 2021: 3
Where
New York 5 · Connecticut 1
Often inspects with
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Inspection history
6 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2021-07-27 | 483 Compounded Solutions in Pharmacy, LLCJul 27, 2021 · Monroe, Connecticut | Monroe, Connecticut | 7 | |
| 2021-06-17 | 483 Mentholatum Company, TheJun 17, 2021 · Orchard Park, New York | Orchard Park, New York | 4 | |
| 2021-05-14 | 483 Pine Pharmaceuticals, LLCMay 14, 2021 · Tonawanda, New York | Tonawanda, New York | 5 | |
| 2020-03-06 | 483 Safetec of America Inc.Mar 6, 2020 · Buffalo, New York | Buffalo, New York | 2 | |
| 2019-08-12 | 483 Fresenius Kabi USA, LLCAug 12, 2019 · Grand Island, New York | Grand Island, New York | 2 | |
| 2019-05-22 | 483 Unither Manufacturing LLCMay 22, 2019 · Rochester, New York | Rochester, New York | 3 |
About this profile
What does Johnna L. Bleem inspect?
Johnna L. Bleem appears on 6 documents on file covering 6 sites, mostly in New York.
What do they cite most often?
21 CFR 211.67 (equipment cleaning and maintenance), followed by 21 CFR 211.113 and 21 CFR 211.192.
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 Johnna L. Bleem is dated Jul 27, 2021.