Warning letter
Biochem Laboratories Inc.: warning letter of Feb 17, 2012
FDA warning letter 204712 · New Jersey District Office
Key facts
| Reference number | 204712 |
|---|---|
| Company | Biochem Laboratories Inc. |
| Subject | CGMP Regulations for Finished Pharmaceuticals/Adulterated |
| Issue date | Feb 17, 2012 |
| Posted date | Feb 17, 2012 |
| Issuing office | New Jersey District Office |
| Product type | Drugs |
| CFR sections cited | 211.160(b), 211.194(c), 211.165(e), 211.68(b), 211.67(a) |
| Inspection city | Lyndhurst |
| Inspection ZIP | 07071 |
| Inspection start date | May 18, 2011 |
| 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: