Warning letter
Health Directions, Inc.: warning letter of Mar 4, 2004
FDA warning letter UCM146243 · Philadelphia District Office
Key facts
| Reference number | UCM146243 |
|---|---|
| Company | Health Directions, Inc. |
| Subject | Lacks Premarket Approval/Unapproved IDE/Adulterated |
| Issue date | Mar 4, 2004 |
| Posted date | Mar 4, 2004 |
| Issuing office | Philadelphia District Office |
| Product type | Devices |
| CFR sections cited | 807.81, 807.81(a) |
| Country | 3 |
| Inspection city | Newtown |
| Inspection ZIP | 18940-1946 |
| Inspection start date | Oct 21, 2003 |
| 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: