Gadal 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 validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(2)).

Passage 2

Your firm failed to qualify your suppliers and adequately test the components used to manufacture your finished drug products, including pediatric over-the-counter (OTC) **(b)(4)** products. For example,

Passage 3

Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedure (21 CFR 211.22(d)).

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.