Pro Numb Tattoo Numbing Spray, 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

Your firm failed to adequately test batches of your drug products before release and distribution. You stated your firm does not perform finished product testing.

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

Your firm failed to establish and follow an adequate 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)).

Passage 5

You failed to demonstrate the quality attributes of your drug products remain acceptable throughout the labeled expiration period. For example, during the inspection, you indicated to the investigator you recorded microbial results on the stability-study data sheet without performing the testing and without any supporting data. You also did not record assay results on your stability-study data sheets for multiple stability time points.

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 (21 CFR 211.100(a)).

Passage 7

Your firm failed to validate your manufacturing processes for your OTC drug products (for example, Pro Numb Tattoo Numbing Spray 5% Lidocaine and Pro Numb Tattoo Numbing Spray 4% Lidocaine for sensitive skin). When asked to provide validation studies for your manufacturing process, you acknowledged not being familiar with process validation requirements.

Passage 8

Your firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacturing of drug products. For example, your QU failed to ensure:

Passage 9

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.