Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-30.
At a glance
Inspections
8
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Mar 2026 – 30 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Dec 2019 – 19 Dec 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Sep 2016 – 30 Sep 2016 | Medical Devices & Rad Health | Clean | |
| 16 Feb 2016 – 29 Feb 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Oct 2013 – 3 Dec 2013 | Medical Devices & Rad Health | WL | View 483 → |
| 22 Mar 2010 | Not recorded | 483 | View 483 → |
| 28 Jan 2008 | Not recorded | Clean | |
| 28 Apr 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Mar 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Melina L Rodriguez-Upton
30 Mar 2026
ISO 13485:2016 Clause 5.6.1
Management review procedures not documented
Cited by Melina L Rodriguez-Upton
30 Mar 2026
ISO 13485:2016 Clause 6.3
Requirements for infrastructure not documented
Cited by Melina L Rodriguez-Upton
30 Mar 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Melina L Rodriguez-Upton
30 Mar 2026
ISO 13485:2016 Clause 7.5.6
Procedures for validation of processes not documented
Cited by Melina L Rodriguez-Upton
Investigators
FDA investigators tied to this site in the record.
Debara R Reese2 insp.
Joseph R Strelnik2 insp.
Melina L Rodriguez-Upton1 insp.
Patrick B Cummings1 insp.
Calvin K Cook1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.130 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 5.6.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Analytical Control Systems, Inc's 5 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