Warning letter
Crystal Laboratory, Inc.: warning letter of Aug 6, 2004
FDA warning letter UCM146543 · Office of Enforcement
Key facts
| Reference number | UCM146543 |
|---|---|
| Company | Crystal Laboratory, Inc. |
| Subject | Biological Product Establishment Standard/Adulterated |
| Issue date | Aug 6, 2004 |
| Posted date | Aug 6, 2004 |
| Issuing office | Office of Enforcement |
| Product type | Biologics |
| CFR sections cited | 680.1(b)(2)(iii), 600.10(b) |
| Country | 3 |
| Inspection city | Luther |
| Inspection ZIP | 73054-8828 |
| Inspection start date | May 5, 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: