Tonia F. Bernard
FDA investigator
Appears on 13 documents from 2016 to 2024, most often at sites in New Jersey. Most often cites automatic, mechanical, and electronic equipment (21 CFR 211.68).
- 13
- Documents on file
- 2.5
- Observations per 483
- 2016
- First seen
- 2024
- Most recent
What they cite most
From 28 observations- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.192Production record review3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.182Equipment cleaning and use log2
Activity by year
2016: 2, 2017: 3, 2018: 2, 2019: 1, 2020: 1, 2021: 1, 2022: 1, 2024: 2
Where
New Jersey 6 · China 4 · New York 2 · Maryland 1
Often inspects with
Is Tonia F. Bernard 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
13 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-11-08 | 483 Lights Medical Manufacture Co., LtdNov 8, 2024 · Tianjin, China | Tianjin, China | 2 | |
| 2024-11-08 | 483 Lights Medical Manufacture Co., Lid No. (9 Quanda Road, Wuging Development AreaNov 8, 2024 · Tianjin, China | Tianjin, China | 2 | |
| 2022-03-04 | 483 Xiamen LP Pharmaceutical Co., Ltd.Mar 4, 2022 · Xiamen, China | Xiamen, China | 2 | |
| 2021-09-29 | 483 Waterstone Pharmaceuticals (Hubei) Co., Ltd.Sep 29, 2021 · Tianmen, China | Tianmen, China | 2 | |
| 2020-10-09 | 483 Millers o f Wycko ffOct 9, 2020 · Wyckoff, New Jersey | Wyckoff, New Jersey | 2 | |
| 2019-08-28 | 483 Athenex Pharma Solutions, LLCAug 28, 2019 · Clarence, New York | Clarence, New York | 1 | |
| 2018-07-26 | 483 Buffalo Pharmacies Inc.Jul 26, 2018 · East Amherst, New York | East Amherst, New York | 1 |
About this profile
What does Tonia F. Bernard inspect?
Tonia F. Bernard appears on 13 documents on file covering 12 sites, most often in New Jersey.
What do they cite most often?
21 CFR 211.68 (automatic, mechanical, and electronic equipment), followed by 21 CFR 211.192 and 21 CFR 211.22.
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 Tonia F. Bernard is dated Nov 8, 2024.