Skyless, 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 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

Passage 2

You failed to perform analytical and microbiological release testing for each batch of your over-the-counter (OTC) topical drug products prior to distribution, including Xpasmo Manteca de Ubre (Cow’s Udder grease) and Xpasmo Arthritis Formula.

Passage 3

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

Passage 4

You failed to test all your incoming raw materials including active pharmaceutical ingredients (API) and other components. You relied on your supplier’s certificate of analysis (COA) in lieu of testing each component lot 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 suppliers’ test results for these attributes.

Passage 5

Your firm failed to establish an adequate Quality Unit (QU) to ensure that:

Passage 6

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.