Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-09.
At a glance
Inspections
7
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Apr 2025 – 9 May 2025 | Human Drugs | 483 | On file |
| 21 Jan 2020 – 29 Jan 2020 | Human Drugs | 483 | On file |
| 6 Jan 2015 – 20 Jan 2015 | Human Drugs | 483 | On file |
| 23 Mar 2012 | Not recorded | WL | On file |
| 5 Aug 2010 | Not recorded | 483 | On file |
| 20 Jan 2009 | Not recorded | 483 | View 483 → |
| 24 Oct 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Jan 2009
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Gayle S Lawson, Vlada Matusovsky
20 Jan 2009
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Gayle S Lawson, Vlada Matusovsky
20 Jan 2009
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Gayle S Lawson, Vlada Matusovsky
20 Jan 2009
21 CFR 211.180(e)(1)
Review of representative number of batches
Cited by Gayle S Lawson, Vlada Matusovsky
20 Jan 2009
21 CFR 211.194(a)
Complete test data included in records
Cited by Gayle S Lawson, Vlada Matusovsky
Investigators
FDA investigators tied to this site in the record.
Vlada Matusovsky2 insp.
Gayle S Lawson2 insp.
Anastasia M Shields1 insp.
Christina K Theodorou1 insp.
Lu Chen1 insp.
David A Oluwo1 insp.
Jaison J Eapen1 insp.
Junho Pak1 insp.
Deborah J Parris1 insp.
Matthew R Noonan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Abbey Color Incorporated's 6 Form 483s
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