Little Moon Essentials, LLC — FDA Warning Letter Findings
US FDAPublished 2024-10-015 findingsDeviation, CAPA, and investigationLaboratory and QC controlsMaterial and supplier controlStability and storageProcess validation
Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22(d)). Your firm failed to establish adequate written procedures defining quality unit (QU) responsibilities and controls. For example, your firm failed to establish adequate procedures for out-of-specification (OOS) investigations, CAPA, equipment qualification and process validation, stability program…
2Laboratory and QC controls
Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)). Your firm failed to perform analytical and microbiological release testing for each batch of your OTC topical drug products prior to distribution, including Asana Kisser (topical analgesic). Drug product…
3Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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 211.84(d)(2)). Your firm failed to test all incoming raw materials used to manufacture your over-the-counter (OTC) drug products, including active pharmaceutical ingredients (API), and other high-risk components. You…
4Stability and storage
Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing. Your firm also failed to establish and follow 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) and 211.137(a)). Your firm failed to establish an adequate stability program, and lacked…
5Process validation
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 failed to demonstrate that you have validated the manufacturing processes for all your drug products and provide assurance you are capable of consistently delivering a quality product. During the inspection, you…
About this record
Extracted automatically from the document US FDA published on 2024-10-01. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
