Michael R. Klapal
FDA investigator
Appears on 5 documents from 2013 to 2019, mostly at sites in New Jersey. Most often cites stability testing (21 CFR 211.166).
- 5
- Documents on file
- 4.0
- Observations per 483
- 2013
- First seen
- 2019
- Most recent
What they cite most
From 16 observations- 21 CFR 211.166Stability testing3
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.192Production record review2
- 21 CFR 211.42(c)(10)(iv)Design and construction features2
- 21 CFR 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
Activity by year
2013: 2, 2015: 1, 2018: 1, 2019: 1
Where
New Jersey 3 · Germany 1 · Pennsylvania 1
Often inspects with
Is Michael R. Klapal coming to your site?
Our team writes custom reports before an inspection: what this investigator cites most, how they write it up, and how your site's history compares, in one brief you can circulate.
Ask about any investigator in Claude or ChatGPT with the AI connector.
Inspection history
5 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-04-16 | 483 KVK-Tech, IncApr 16, 2019 · Newtown, Pennsylvania | Newtown, Pennsylvania | 7 | |
| 2018-02-09 | 483 Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)Feb 9, 2018 · Ravensburg, Germany | Ravensburg, Germany | 1 | |
| 2015-09-30 | 483 Pharmacy CreationsSep 30, 2015 · Randolph, New Jersey | Randolph, New Jersey | 3 | |
| 2013-09-03 | Response Pharmacy Creations, LLCSep 3, 2013 · Randolph, New Jersey | Randolph, New Jersey | — | |
| 2013-08-19 | 483 Pharmacy CreationsAug 19, 2013 · Randolph, New Jersey | Randolph, New Jersey | 5 |
About this profile
What does Michael R. Klapal inspect?
Michael R. Klapal appears on 5 documents on file covering 3 sites, mostly in New Jersey.
What do they cite most often?
21 CFR 211.166 (stability testing), followed by 21 CFR 211.113(b) 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 Michael R. Klapal is dated Apr 16, 2019.