Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-07.
At a glance
Inspections
3
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Apr 2026 – 7 Apr 2026 | Human Drugs | 483 | View 483 → |
| 8 Nov 2021 – 30 Nov 2021 | Human Drugs | 483 | View 483 → |
| 4 Jun 2018 – 18 Jun 2018 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Nov 2021
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Robert J Martin, Daniel L Zheng, Leanna M Slarsky
30 Nov 2021
21 CFR 211.67(b)(3)
Cleaning SOPs/instructions
Cited by Robert J Martin, Daniel L Zheng, Leanna M Slarsky
30 Nov 2021
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Robert J Martin, Daniel L Zheng, Leanna M Slarsky
30 Nov 2021
21 CFR 211.84(d)(2)
Reports of Analysis (Components)
Cited by Robert J Martin, Daniel L Zheng, Leanna M Slarsky
Investigators
FDA investigators tied to this site in the record.
Ogechi C Nna1 insp.
Armen H Youssoufian1 insp.
Robert J Martin1 insp.
Daniel L Zheng1 insp.
Leanna M Slarsky1 insp.
Erik W Koester1 insp.
Stephen C Smith1 insp.
Yaodong Huang1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(c)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Catalent Massachusetts, LLC'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