Profounda, Inc.

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 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 2

Your firm failed to provide data to demonstrate that you have validated manufacturing processes for your over-the-counter (OTC) drug products, including but not limited to “Rhinase D.” Your firm lacked qualification protocols, reports, or studies to determine if manufacturing processes were in a state of control and appropriate acceptance criteria were met.

Passage 3

Your firm failed to establish 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 4

Your firm failed to establish an adequate stability program and determine appropriate expiration dates for the OTC drug products that you manufacture. For example, you assigned a five-year expiry period to “Rhinase D” drug product batch 1J02 (30g). At the time of inspection, only **(b)(4)** of real-time and accelerated data were available. You lacked sufficient stability data to substantiate the “Rhinase D” five-year expiry period.

Passage 5

Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).

Passage 6

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

Passage 7

Your firm failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and released for use by the quality control unit (21 CFR 211.84(a)).

Passage 8

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.