Analytical Food Laboratories, 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 and follow required laboratory control mechanisms, and 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(a) and 211.160(b)).

Passage 2

Your firm failed to adequately validate the analytical methods used to test your customers’ drug products. For example, you conducted assay testing of over-the-counter (OTC) drug products, **(b)(4)** oral solution and **(b)(4)** tablets, but indicated during the inspection that your firm did not have written procedures for the assay method and had not validated the test methods you used.

Passage 3

Your firm failed to adequately establish and follow procedures for growth promotion testing of your microbiological media to assure suitability before use. For example, growth promotion tests for media batches 06-19-23-3 and 06-19-23-5 were performed with only one indicator microorganism, Staphylococcus aureus, and did not include the other challenge microorganisms listed in USP <61>. Both media were subsequently used to test a sample of **(b)(4)** tablets.

Passage 4

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.