Maria E. Estrella
FDA investigator
Appears on 6 documents from 2017 to 2026, mostly at sites in India. Most often cites laboratory records (21 CFR 211.194).
- 6
- Documents on file
- 4.0
- Observations per 483
- 2017
- First seen
- 2026
- Most recent
What they cite most
From 21 observations- 21 CFR 211.194Laboratory records2
- 21 CFR 211.22(a)Responsibilities of quality control unit2
- 21 CFR 211.42(a)Design and construction features2
- 21 CFR 111.103What are the requirements under this subpart F for written procedures?1
- 21 CFR 111.455(a)What requirements apply to holding components, dietary supplements, packaging, and labels?1
- 21 CFR 111.475(b)Under this subpart M, what records must you make and keep?1
Activity by year
2017: 2, 2018: 1, 2019: 1, 2022: 1, 2026: 1
Where
India 3 · New Jersey 2 · Mexico 1
Often inspects with
Is Maria E. Estrella coming to your site?
Our team writes custom reports before an inspection: what this investigator cites most, how they write it up, and how your site's history compares, in one brief you can circulate.
Ask about any investigator in Claude or ChatGPT with the AI connector.
Inspection history
6 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-01-30 | 483 Safrel Pharmaceuticals LLCJan 30, 2026 · Dayton, New Jersey | Dayton, New Jersey | 10 | |
| 2022-12-09 | 483 Form 483 · FEI 3002806479Dec 9, 2022 · Lerma, Mexico | Lerma, Mexico | 2 | |
| 2019-08-02 | 483 HIKAL LIMITEDAug 2, 2019 · Bengaluru, India | Bengaluru, India | — | |
| 2018-10-23 | 483 Endo USA, Inc.Oct 23, 2018 · Cranbury, New Jersey | Cranbury, New Jersey | 5 | |
| 2017-03-10 | 483 Alkem Laboratories Limited Village- Thana, NalagarhMar 10, 2017 · Baddi, India | Baddi, India | 2 | |
| 2017-03-01 | 483 Cadila Healthcare Limited Swaraj Majra, Juddi Kalan, TehsilMar 1, 2017 · Baddi, India | Baddi, India | 1 |
About this profile
What does Maria E. Estrella inspect?
Maria E. Estrella appears on 6 documents on file covering 6 sites, mostly in India.
What do they cite most often?
21 CFR 211.194 (laboratory records), followed by 21 CFR 211.22(a) and 21 CFR 211.42(a).
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 Maria E. Estrella is dated Jan 30, 2026.