Warning Letters | FDA
Main FDA Warning Letter PageLearn about the types of warning letters on FDA's website. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA …
Shadow Holdings DBA Bocchi Labs - 561273 - 02/06/2019 | FDA
This warning letter also summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.
Compounding: Inspections, Recalls, and other Action | FDA
Jun 16, 2025 · : Federal Court Enters Consent Decree Against Ranier's Rx Laboratory and Owner for Manufacturing Purportedly Sterile Drug Products in Unsanitary Conditions (02/06/2019)
Warning & Notice of Violation Letters to Pharmaceutical Companies
Oct 25, 2023 · Visit the FOI page for instructions on how to submit an FOI request or for more information on the status of an issue in a particular warning letter or notice of violation.
About Warning and Close-Out Letters | FDA
The FDA office that issued the Warning Letter will issue the close-out letter, and that office may be contacted for information on a particular Warning Letter or close-out letter.
CDRH Transparency: Compliance & Enforcement | FDA
FDA Medical Device 2014 Quality System Data - Analysis of 2014 Inspection Observations and Warning Letter Cites
Search | FDA
FDA issued Warning Letters to the following firms, citing cosmetic products as … do not meet the threshold of regulatory significance for a warning letter and to request correction of...
Warning Letters Related to Cosmetics | FDA
If you would like to obtain available additional information on the current status of an issue in a particular Warning Letter on this website, please contact FDA or the recipient of the...
Letters to Industry | FDA
A Warning Letter is the agency's principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act (the Act)."
Copy of the disclosable portions of the company response and all other correspondence between FDA and representative of Zarbee`s regarding the 06/27/2014 Warning Letter issued to Zarbee`s,...