What happened
Original notice title
NDAL Mfg Inc. MARCS-CMS 621656, March 28, 2022
From the archived source record
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). In addition, MANUKA HONEY ALLERCLEANSE Nasal Spray, MANUKA HONEY SINUS CLEANSER, and MANUKA HONEY EXTRA STRENGTH NASAL SPRAY ALLERCLEANSE are unapproved new drugs in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). These violations are described in more detail below. During our inspection, our investigators observed specific violations including, but not limited to, the following. You firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). You did not provide a detailed risk assessment addressing the potential effects of releasing drug product to the market without established specifications to ensure their identity, strength, quality, and purity. In addition, there was a lack of detail for qualifying and overseeing your CMOs to ensure adherence to CGMP regulations. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, at [see original source] . Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls. 2. Your firm failed to perform a thorough investigation into the microbial contamination that occurred with ManukaGuard Allercleanse nasal spray lot 2010045, manufactured for your firm by your CMO, (b)(4) .
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- a57e34f1e530
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →