Felix Maldonado
FDA investigator
Appears on 6 documents from 2009 to 2019, mostly at sites in New York. Most often cites general requirements (21 CFR 211.160).
- 6
- Documents on file
- 10.7
- Observations per 483
- 2009
- First seen
- 2019
- Most recent
What they cite most
From 61 observations- 21 CFR 211.160General requirements6
- 21 CFR 211.194Laboratory records6
- 21 CFR 211.166Stability testing4
- 21 CFR 211.192Production record review4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.110Sampling and testing of in-process materials and drug products3
Activity by year
2009: 1, 2011: 1, 2013: 1, 2015: 1, 2016: 1, 2019: 1
Where
New York 3 · India 2 · China 1
Often inspects with
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Inspection history
6 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-02-22 | 483 SOFTGEL HEALTHCARE PRIVATE LIMITEDFeb 22, 2019 · Chengalpattu, India | Chengalpattu, India | 2 | |
| 2016-11-16 | 483 Sun Pharmaceuticals Industries, IncNov 16, 2016 · S.A.S. Nagar, Mohali, India | S.A.S. Nagar, Mohali, India | 7 | |
| 2015-07-20 | 483 Hi-Tech Pharmacal, an AKORN CompanyJul 20, 2015 · Amityville, New York | Amityville, New York | 3 | |
| 2013-07-18 | 483 Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)Jul 18, 2013 · Jinan, China | Jinan, China | 12 | |
| 2011-07-08 | 483 APP PharmaceuticalsJul 8, 2011 · Grand Island, New York | Grand Island, New York | 16 | |
| 2009-08-12 | 483 Ohm Laboratories, Inc.Aug 12, 2009 · Gloversville, New York | Gloversville, New York | 24 |
About this profile
What does Felix Maldonado inspect?
Felix Maldonado appears on 6 documents on file covering 6 sites, mostly in New York.
What do they cite most often?
21 CFR 211.160 (general requirements), followed by 21 CFR 211.194 and 21 CFR 211.166.
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 Felix Maldonado is dated Feb 22, 2019.