Warning letter
Custom Assemblies, Inc.: warning letter of Apr 6, 2018
FDA warning letter 540535 · Division of Medical Device and Radiological Health Operations Central
Key facts
| Reference number | 540535 |
|---|---|
| Company | Custom Assemblies, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Apr 6, 2018 |
| Posted date | Apr 17, 2018 |
| Issuing office | Division of Medical Device and Radiological Health Operations Central |
| Product type | Devices |
| CFR sections cited | 803.3, 820, 803.50(a) |
| Inspection city | Pine Level |
| Inspection ZIP | 27568 |
| Inspection start date | Jul 17, 2017 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: