Patric C. Klotzbuecher
FDA investigator · also recorded as Patrie C. Klotzbuecher, Patrick C. Klotzbuecher
Appears on 13 documents from 2014 to 2019, most often at sites in India. Most often cites general requirements (21 CFR 211.160).
- 13
- Documents on file
- 4.5
- Observations per 483
- 2014
- First seen
- 2019
- Most recent
What they cite most
From 58 observations- 21 CFR 211.160General requirements9
- 21 CFR 211.192Production record review9
- 21 CFR 211.22Responsibilities of quality control unit9
- 21 CFR 211.68Automatic, mechanical, and electronic equipment5
- 21 CFR 211.194Laboratory records4
- 21 CFR 211.113Control of microbiological contamination3
Activity by year
2014: 1, 2016: 4, 2017: 1, 2018: 1, 2019: 6
Where
India 6 · New York 2 · Germany 1 · Illinois 1 · Japan 1 · Netherlands 1
Often inspects with
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Inspection history
13 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-10-18 | 483 Regeneron Pharmaceuticals IncOct 18, 2019 · Rensselaer, New York | Rensselaer, New York | 1 | |
| 2019-08-09 | 483 Takeda Pharmaceutical Company LimitedAug 9, 2019 · Yodogawa-Ku, Japan | Yodogawa-Ku, Japan | 4 | |
| 2019-06-06 | 483 NATCO PHARMA LIMITEDJun 6, 2019 · Kothur, India | Kothur, India | 9 | |
| 2019-05-28 | 483 Intas Pharmaceuticals LimitedMay 28, 2019 · Ahmedabad, India | Ahmedabad, India | 7 | |
| 2019-04-16 | 483 KVK-Tech, IncApr 16, 2019 · Newtown, Pennsylvania | Newtown, Pennsylvania | 7 | |
| 2019-02-21 | 483 Rottendorf Pharma GmbHFeb 21, 2019 · Ennigerloh, Germany | Ennigerloh, Germany | 1 | |
| 2018-04-13 | 483 Cipla LimitedApr 13, 2018 · Pithampur, India | Pithampur, India | 1 |
About this profile
What does Patric C. Klotzbuecher inspect?
Patric C. Klotzbuecher appears on 13 documents on file covering 13 sites, most often in India.
What do they cite most often?
21 CFR 211.160 (general requirements), followed by 21 CFR 211.192 and 21 CFR 211.22.
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 Patric C. Klotzbuecher is dated Oct 18, 2019.