Kaylaan 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 211.165(a)).

Passage 2

You failed to perform release testing of batches of Kaylaan Toothpaste Tablets with Fluoride. During the inspection, you stated no finished product release testing was conducted for identity and strength of the active ingredient. You manufactured and distributed over **(b)(4)** batches of Kaylaan Toothpaste Tablets with Fluoride since 2021 without testing. Our inspection also noted no in-process testing was conducted during the manufacture of Kaylaan Toothpaste Tablets with Fluoride.

Passage 3

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 211.84(d)(2)).

Passage 4

You failed to conduct any test to confirm the identity of incoming raw materials. For example, you stated sodium fluoride, which is the active ingredient in your Kaylaan Toothpaste Tablets with Fluoride, is not subjected to chemical analysis. Furthermore, you stated you rely on the supplier’s certificate of analysis (COA) in lieu of conducting your own testing.

Passage 5

Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)).

Passage 6

Your firm failed to establish adequate 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. Your firm also failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.100(a) and 211.67(b)).

Passage 7

You failed to validate your processes and qualify the equipment used to manufacturer your OTC drug products. During the inspection, you stated the manufacturing process has been the same since 2021, but also stated the formula has been changed since that time. This change was made without adequate change control evaluation to assess the impact on finished product quality. Furthermore, the inspection noted numerous product quality defects including, but not limited to, chipping and sticking tablets.

Passage 8

Your firm failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.58).

Passage 9

You failed to maintain your over-the-counter (OTC) drug manufacturing facility in a good state of repair. Our investigator observed paint peeling from the floor, and windows that were cracked and repaired with tape. In addition, vents and light fixtures above tablet presses were covered in white powder. It is essential your facility is in a good state of repair, and sanitary conditions are maintained to ensure ongoing suitability for drug manufacturing.

Passage 10

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.