Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-28.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Mar 2025 – 28 Mar 2025 | Human Drugs | 483 | View 483 → |
| 13 Jul 2021 – 21 Jul 2021 | Medical Devices & Rad Health | Clean | |
| 13 Mar 2018 – 16 Mar 2018 | Medical Devices & Rad Health | Clean | |
| 16 May 2017 – 18 May 2017 | Medical Devices & Rad Health | Clean | |
| 24 Mar 2015 – 31 Mar 2015 | Medical Devices & Rad Health | Clean | |
| 8 Apr 2014 – 7 May 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Jul 2011 | Not recorded | 483 | View 483 → |
| 11 Mar 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Mar 2025
21 CFR 211.103
Actual vs. theoretical yields not determined
Cited by Santos E Camara, Satheesh K Podaralla
28 Mar 2025
21 CFR 211.165(a)
Testing and release for distribution
Cited by Santos E Camara, Satheesh K Podaralla
28 Mar 2025
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Santos E Camara, Satheesh K Podaralla
28 Mar 2025
21 CFR 211.170(b)
Annual visual exams of drug products
Cited by Santos E Camara, Satheesh K Podaralla
28 Mar 2025
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Santos E Camara, Satheesh K Podaralla
Investigators
FDA investigators tied to this site in the record.
Laiza V Garcia3 insp.
Wanda J Torres2 insp.
Santos E Camara1 insp.
Satheesh K Podaralla1 insp.
MDSAP WilliamsA1 insp.
Nydia E Colon1 insp.
Marilyn Santiago1 insp.
Frances L Dejesus1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Boston Scientific Corporation's 3 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat