Free Drug Registration and Workshop Webcast, October 8, 2020.
Topics Covered: 1. Labeler Code Requests, 2. Establishment Registration, 3. Drug Listing, 4. 503B Compounder Product Reporting using CDER Direct, 5. Establishment Registration and Drug Listing Compliance Program, and 6. All sessions include a Q&A panel. Control/Click here >> REGISTER
Hand sanitizers Recalled due to presence of undeclared Methanol (Wood Alcohol) Methanol is not an acceptable ingredient for hand sanitizers and must not be used due to its toxic effects. Companies included in the recall:
DDM Vission, S.A. DE C.V. - Cleaner Hand Sanitizer AJR Trading LLC - bio aaa Advance Hand Sanitizer 480 ml bottles
Medek - M Hand Sanitizer Alcohol Antiseptic 80%
Open Book Extracts - Always Be Clean Hand Sanitizer and Just Hand Sanitizer
Also CorgioMed, LLC - Leefree Instant Hand Sanitizer Aloe Vera is improperly labeled "edible alcohol"
Warning Letters HFL Solutions, LLC, Sam Robbins Ahdoot, Owner; Playa Vista, CA 90094
1. You promote CholesLo as a dietary supplement, but it contains Lovastatin an active ingredient in Mevacor and its generic counterparts, consequently it cannot be marketed as a dietary supplement.
2. Your AlphaViril, Blood Flow Optimizer, Blood Pressure Optimizer, Blood Sugar Optimizer, CHEATmeals, CholesLo, Inflame & Pain Relief, LeanOptimizer, Perfect Vitamin D & K, and ProVanax products are not generally recognized as safe and effective for the uses you promote and therefore are "new drugs" that have not been approved by the FDA and cannot be introduced into interstate commerce.
Essential Pharmaceutical Corp, Bruce Y. Lin, President; Pomona, CA 91768
1. Your firm manufactures and distributes "BIO-MINT Nasal Spray," which is an unapproved new drug and is being marketed as a nonprescription, over-the-counter (OTC) drug product. "BIO-MINT Nasal Spray" is a drug under section 201(g)(1)(B) of the Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body.
2. Our inspection revealed serious violations of the FDA's regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). Specifically,
A. You failed to establish specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)
B. You failed to establish product specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement, as required by 21 CFR 111.70(e).
C. You failed to establish specifications for dietary supplement labels, as required by 21 CFR 111.70(d).
D. You failed to establish and follow all required written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting reprocessing as required by 21 CFR 111.103.
E. You failed to prepare a Master Manufacturing Records (MMRs) that includes the information specified in 21 CFR 111.210. One example is that a complete list of components to be used is not included in the MMRs as required by 21 CFR 111.210(b).
F. You failed to prepare a batch production record every time you manufactured a batch of dietary supplements with the information required by 21 CFR 111.255(b).
G. You did not maintain, clean and sanitize equipment, and contact surfaces used to manufacture or hold components or dietary supplements as required by 21 CFR 111.27(d).
H. And Much More - see the Warning Letter for complete explanations
LEC Custom Products, Inc. Jeremy Willard, CEO; Brampton ON L6T 5G5 Canada
During our inspection our investigator observed the following some of which are repeat violations:
1. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).
2. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). Your firm lacked a process validation program.
3. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).
4. Your firm failed to establish a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
5. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)).
6. Your firm failed to establish an adequate quality unit and the responsibilities, and procedures applicable to the quality control unit were not in writing and fully followed (21 CFR 211.22(a)&(d)).
Front Door Pharmacy, LLC dba Pure Pharmacy, Henry Shui, Owner; Houston, TX 77054 Based on our inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).
1. The FDA investigator noted that drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA.
a. An operator exposed his bare hands by changing gloves inside the ISO 5 LAF hood during aseptic operations. Furthermore, once donned, the gloves did not cover the skin and hair around his wrists.
b. The ISO-classified areas had visibly dirty equipment and difficult to clean surfaces.
c. Your firm maintained the ISO 5 LAF hood in a powered-off state until (b)(4) prior to beginning aseptic processing and did not disinfect with a sporicidal agent prior to producing sterile drug products.
d. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area.
e. Air vents within your classified areas were located on the ceiling, adjacent to the HEPA filters. Therefore, your firm had no assurance of proper air circulation within the classified areas.
f. Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area with gloved hands and then engaged in aseptic processing without changing or sanitizing gloves. And much more....
Panacea Biotec Limited, Rajesh Jain, Managing Director, New Delhi 110044 Delhi India
During our inspection, our investigators observed:
1. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
2. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).