Warning letter
Keystone Laboratories Inc: warning letter of Mar 18, 2013
FDA warning letter 373000 · New Orleans District Office
Key facts
| Reference number | 373000 |
|---|---|
| Company | Keystone Laboratories Inc |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Issue date | Mar 18, 2013 |
| Posted date | Mar 18, 2013 |
| Issuing office | New Orleans District Office |
| Product type | Drugs |
| CFR sections cited | 201.15(c)(2), 358, 211.67(a), 211.84(a), 211.100(b), 358.710(a), 358.750(c), 201.66, 210, 211.58, 211.63 |
| Inspection city | Memphis |
| Inspection ZIP | 38106 |
| Inspection start date | Aug 15, 2012 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: