Warning letter
Klein Laboratories, Inc.: warning letter of Jul 17, 2014
FDA warning letter 416463 · New England District Office
Key facts
| Reference number | 416463 |
|---|---|
| Company | Klein Laboratories, Inc. |
| Subject | Unapproved New Drug/Adulterated |
| Issue date | Jul 17, 2014 |
| Posted date | Jul 29, 2014 |
| Issuing office | New England District Office |
| Product type | Food/Cosmetics |
| CFR sections cited | 111.70(e), 111, 111.103, 111.260, 111.553, 111.70(b), 111.70(b)(1), 111.75(a)(2)(ii), 111.83(a), 111.155(c), 111.205(a), 111.255(b) and 7 more |
| Inspection city | North Haven |
| Inspection ZIP | 06473 |
| Inspection start date | Aug 22, 2013 |
| 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: