Jose A. Cruz-Gonzalez
FDA investigator
Appears on 11 documents from 2013 to 2019, most often at sites in Puerto Rico. Most often cites control of microbiological contamination (21 CFR 211.113).
- 11
- Documents on file
- 7.5
- Observations per 483
- 2013
- First seen
- 2019
- Most recent
What they cite most
From 76 observations- 21 CFR 211.113Control of microbiological contamination14
- 21 CFR 211.160General requirements11
- 21 CFR 211.42Design and construction features7
- 21 CFR 211.67Equipment cleaning and maintenance7
- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.188Batch production and control records4
Activity by year
2013: 1, 2014: 1, 2015: 3, 2017: 1, 2018: 2, 2019: 3
Where
Puerto Rico 4 · India 2 · Canada 1 · Germany 1 · Japan 1 · North Carolina 1
Often inspects with
Cassandra L. Abellard· Dennis Cantellops· Miguel A. Martinez
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Inspection history
11 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-08-23 | 483 Eckert & Ziegler Radiopharma GmbHAug 23, 2019 · Berlin, Germany | Berlin, Germany | 13 | |
| 2019-06-04 | 483 Indoco Remedies LimitedJun 4, 2019 · Vasco Da Gama, India | Vasco Da Gama, India | 2 | |
| 2019-03-05 | 483 Astellas Pharma Inc.Mar 5, 2019 · Takaoka, Japan | Takaoka, Japan | 8 | |
| 2018-12-14 | 483 Aurobindo Pharma Limited - Unit IV Plot Nos. 4, 34 To 48, Epip, Tsiic, IdaDec 14, 2018 · Medak District, India | Medak District, India | 1 | |
| 2018-03-16 | 483 Rohto-Mentholatum (Vietnam) Co., Ltd.Mar 16, 2018 · Thuan An, Vietnam | Thuan An, Vietnam | 14 | |
| 2017-09-27 | 483 Les Produits Chimiques B.G.R. Inc.Sep 27, 2017 · Pointe-Claire, Canada | Pointe-Claire, Canada | 13 | |
| 2015-07-02 | 483 Pfizer Pharmaceuticals LLCJul 2, 2015 · Barceloneta, Puerto Rico | Barceloneta, Puerto Rico | 4 |
About this profile
What does Jose A. Cruz-Gonzalez inspect?
Jose A. Cruz-Gonzalez appears on 11 documents on file covering 11 sites, most often in Puerto Rico.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.160 and 21 CFR 211.42.
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 Jose A. Cruz-Gonzalez is dated Aug 23, 2019.