Daniel J. Roberts
FDA investigator
Appears on 14 documents from 2011 to 2017, mostly at sites in India. Most often cites production record review (21 CFR 211.192).
- 14
- Documents on file
- 5.9
- Observations per 483
- 2011
- First seen
- 2017
- Most recent
What they cite most
From 80 observations- 21 CFR 211.192Production record review8
- 21 CFR 211.194Laboratory records6
- 21 CFR 211.160General requirements5
- 21 CFR 211.22Responsibilities of quality control unit5
- 21 CFR 211.68Automatic, mechanical, and electronic equipment5
- 21 CFR 211.113Control of microbiological contamination4
Activity by year
2011: 2, 2013: 1, 2014: 1, 2015: 3, 2016: 4, 2017: 3
Where
India 8 · California 5 · Canada 1
Often inspects with
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Inspection history
14 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2017-05-10 | 483 Intas Pharmaceuticals LimitedMay 10, 2017 · Ahmedabad, India | Ahmedabad, India | 14 | |
| 2017-04-13 | 483 Sun Pharmaceuticals Industries Ltd.Apr 13, 2017 · Dadra, India | Dadra, India | 11 | |
| 2017-02-01 | 483 Mylan Laboratories LimitedFeb 1, 2017 · Bollaram, Jinnaram Mandal, Medak District, India | Bollaram, Jinnaram Mandal, Medak District, India | 1 | |
| 2016-11-16 | 483 Sun Pharmaceuticals Industries, IncNov 16, 2016 · S.A.S. Nagar, Mohali, India | S.A.S. Nagar, Mohali, India | 7 | |
| 2016-08-19 | 483 Form 483 · FEI 3004058356Aug 19, 2016 · Pune, India | Pune, India | 1 | |
| 2016-07-16 | 483 Sun Pharmaceuticals Industries, Inc. SEZ Unit-l, Plot A-41, Industrial Area, Phase VIII-AJul 16, 2016 · S.A.S, India | S.A.S, India | 2 | |
| 2016-02-12 | 483 Amoli Organics Pvt. LimitedFeb 12, 2016 · Vapi, India | Vapi, India | 12 |
About this profile
What does Daniel J. Roberts inspect?
Daniel J. Roberts appears on 14 documents on file covering 12 sites, mostly in India.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.194 and 21 CFR 211.160.
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 Daniel J. Roberts is dated May 10, 2017.