Overview
- 9 public-safe observations are available for this inspection.
- 9 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
24 Mar 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Matthew D Schnittker, Karen A Briggs, Jordan S Burkdoll
24 Mar 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Matthew D Schnittker, Karen A Briggs, Jordan S Burkdoll
24 Mar 2026
21 CFR 211.170(b)
Annual visual exams of drug products
Cited by Matthew D Schnittker, Karen A Briggs, Jordan S Burkdoll
24 Mar 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Matthew D Schnittker, Karen A Briggs, Jordan S Burkdoll
24 Mar 2026
21 CFR 211.198(b)(2)
Written record of complaint to include findings, follow-up
Cited by Matthew D Schnittker, Karen A Briggs, Jordan S Burkdoll
Inspected site
CICooperSurgical, Inc.North Tonawanda, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | 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 7.4.1 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 observations
The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere