Warning letter
Bio Compression Systems: warning letter of Jul 26, 2004
FDA warning letter UCM146524 · New Jersey District Office
Key facts
| Reference number | UCM146524 |
|---|---|
| Company | Bio Compression Systems |
| Subject | Quality System Regulation for Medical Devices/Adulterated |
| Issue date | Jul 26, 2004 |
| Posted date | Jul 26, 2004 |
| Issuing office | New Jersey District Office |
| Product type | Devices |
| CFR sections cited | 807.81, 820 |
| Country | 3 |
| Inspection city | Moonachie |
| Inspection ZIP | 07074-1703 |
| Inspection start date | Mar 2, 2004 |
| Letter on fda.gov | web.archive.org |
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: