Warning letter
Organics Corporation of America DBA Ambix Laboratories: warning letter of Feb 22, 2013
FDA warning letter 322958 · New Jersey District Office
Key facts
| Reference number | 322958 |
|---|---|
| Company | Organics Corporation of America DBA Ambix Laboratories |
| Subject | CGMP/Dietary Supplements/Adulterated |
| Issue date | Feb 22, 2013 |
| Posted date | Feb 22, 2013 |
| Issuing office | New Jersey District Office |
| Product type | Food/Cosmetics |
| CFR sections cited | 111.75(a)(2), 111.80(a), 111, 111.35(b)(1)(iii), 111.35(b)(2), 111.70(a), 111.70(b), 111.75(a)(2)(ii), 111.455(a), 111.75(a)(1), 111.75(a)(1)(i), 111.75(c) |
| Inspection city | Totowa |
| Inspection ZIP | 07512 |
| Inspection start date | Apr 9, 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: