Marie B. Buen-Bigornia
FDA investigator
Appears on 7 documents from 2011 to 2019, most often at sites in Colorado. Most often cites general requirements (21 CFR 211.160).
- 7
- Documents on file
- 5.3
- Observations per 483
- 2011
- First seen
- 2019
- Most recent
What they cite most
From 32 observations- 21 CFR 211.160General requirements3
- 21 CFR 211.25Personnel qualifications3
- 21 CFR 118.10(a)(3)(ii)Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan2
- 21 CFR 118.4(b)(2)Salmonella Enteritidis (SE) prevention measures2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
Activity by year
2011: 2, 2013: 1, 2016: 2, 2018: 1, 2019: 1
Where
Colorado 3 · India 2 · Illinois 1 · New York 1
Often inspects with
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Inspection history
7 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-11-13 | 483 EUGIA PHARMA SPECIALITIES LIMITEDNov 13, 2019 · Sangareddy, India | Sangareddy, India | 14 | |
| 2018-04-24 | 483 Amneal Pharmaceuticals Private LimitedApr 24, 2018 · Ahmedabad, India | Ahmedabad, India | 1 | |
| 2016-07-15 | 483 Hi-Tech Pharmacal, an AKORN CompanyJul 15, 2016 · Amityville, New York | Amityville, New York | 1 | |
| 2016-07-11 | 483 Xttrium Laboratories, IncJul 11, 2016 · Mount Prospect, Illinois | Mount Prospect, Illinois | 6 | |
| 2013-08-30 | 483 Front Range Laboratories, IncorporatedAug 30, 2013 · Loveland, Colorado | Loveland, Colorado | 5 | |
| 2011-05-12 | EIR Sparboe Farms, Inc.May 12, 2011 · Hudson, Colorado | Hudson, Colorado | — | |
| 2011-05-12 | 483 Sparboe Farms, IncMay 12, 2011 · Hudson, Colorado | Hudson, Colorado | 5 |
About this profile
What does Marie B. Buen-Bigornia inspect?
Marie B. Buen-Bigornia appears on 7 documents on file covering 6 sites, most often in Colorado.
What do they cite most often?
21 CFR 211.160 (general requirements), followed by 21 CFR 211.25 and 21 CFR 118.10(a)(3)(ii).
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 Marie B. Buen-Bigornia is dated Nov 13, 2019.