Monica C. Burgos Garcia
FDA investigator
Appears on 4 documents from 2019 to 2024, mostly at sites in India. Most often cites design controls (21 CFR 820.30).
- 4
- Documents on file
- 4.0
- Observations per 483
- 2019
- First seen
- 2024
- Most recent
What they cite most
From 16 observations- 21 CFR 820.30Design controls4
- 21 CFR 211.160General requirements3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.165(d)Testing and release for distribution1
Activity by year
2019: 3, 2024: 1
Where
India 2 · Missouri 1 · Puerto Rico 1
Often inspects with
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-06-05 | 483 Meridian Medical Technologies, LLCJun 5, 2024 · St. Louis, Missouri | St. Louis, Missouri | 9 | |
| 2019-10-25 | 483 Medtronic Puerto Rico Operations Co. Ceiba Norte Industrial Park, 50 Road 31Oct 25, 2019 · Juncos, Puerto Rico | Juncos, Puerto Rico | 1 | |
| 2019-06-21 | 483 Dr. Reddy's Laboratories Ltd. Pl — PS Ql - QS, Phase III, VSEZ, DuvvadaJun 21, 2019 · Visakhapatnam, India | Visakhapatnam, India | 2 | |
| 2019-06-11 | 483 Sun Pharmaceutical Industries Ltd.Jun 11, 2019 · Halol, India | Halol, India | 4 |
About this profile
What does Monica C. Burgos Garcia inspect?
Monica C. Burgos Garcia appears on 4 documents on file covering 4 sites, mostly in India.
What do they cite most often?
21 CFR 820.30 (design controls), followed by 21 CFR 211.160 and 21 CFR 211.113.
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 Monica C. Burgos Garcia is dated Jun 5, 2024.