Little Moon Essentials, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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)).

Passage 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 relied on your supplier’s certificate of analysis (COA) in lieu of testing each component for purity, strength, identity, and quality. You also did not establish a supplier qualification program to assess (i.e., initially, and periodically) the reliability of your supplier’s test results for these attributes.

Passage 3

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)).

Passage 4

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).

Passage 5

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)).

Passage 6

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.

Passage 7

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)).

Passage 8

Your firm failed to establish an adequate stability program, and lacked chemical and microbial testing data to demonstrate that your OTC drug products will remain acceptable throughout their assigned five-year expiry period.

Passage 9

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)).

Passage 10

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, reserve sample program, recalls, and annual product reviews.

Passage 11

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.