Cheryl Clausen
FDA investigator · also recorded as Ph Pe Cheryl Clausen, Y. Cheryl Clausen
Appears on 18 documents from 2016 to 2020, mostly at sites in India. Most often cites responsibilities of quality control unit (21 CFR 211.22).
- 18
- Documents on file
- 7.1
- Observations per 483
- 2016
- First seen
- 2020
- Most recent
What they cite most
From 120 observations- 21 CFR 211.22Responsibilities of quality control unit15
- 21 CFR 211.160General requirements13
- 21 CFR 211.192Production record review10
- 21 CFR 211.68Automatic, mechanical, and electronic equipment9
- 21 CFR 211.188Batch production and control records8
- 21 CFR 211.194Laboratory records8
Activity by year
2016: 2, 2017: 3, 2018: 6, 2019: 6, 2020: 1
Where
India 11 · Japan 4 · China 2 · South Africa 1
Often inspects with
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Inspection history
18 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2020-01-31 | 483 Daito Pharmaceutical Co., LtdJan 31, 2020 · Toyama-City, Japan | Toyama-City, Japan | 10 | |
| 2019-11-08 | 483 Sun Pharmaceutical Industries LimitedNov 8, 2019 · Bharuch, India | Bharuch, India | 3 | |
| 2019-09-26 | 483 Chugai Pharma Manufacturing Co., LtdSep 26, 2019 · Utsunomiya, Japan | Utsunomiya, Japan | 4 | |
| 2019-09-13 | 483 MicroBiopharm Japan Co., Ltd.Sep 13, 2019 · Iwata, Japan | Iwata, Japan | 5 | |
| 2019-03-29 | 483 Sun Pharmaceutical Industries LimitedMar 29, 2019 · Dadra, India | Dadra, India | 11 | |
| 2019-03-20 | 483 CIPLA LIMITEDMar 20, 2019 · Pune, India | Pune, India | 18 | |
| 2019-02-08 | 483 Dr. Reddy's Laboratories Ltd. No 41 Quthbullapur MandalFeb 8, 2019 · Bachupally, India | Bachupally, India | 1 |
About this profile
What does Cheryl Clausen inspect?
Cheryl Clausen appears on 18 documents on file covering 16 sites, mostly in India.
What do they cite most often?
21 CFR 211.22 (responsibilities of quality control unit), followed by 21 CFR 211.160 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 Cheryl Clausen is dated Jan 31, 2020.