GC America, 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 test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Passage 2

Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug products and to test an adequate number of batches of each drug product to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a) and 211.166(b)).

Passage 3

Your firm failed to establish a stability program with adequate data from long-term or accelerated storage conditions, demonstrating that drug products remain acceptable throughout the labeled expiry period. For example, the only stability data provided for **(b)(4)** consisted of a single batch tested for **(b)(4)** at **(b)(4)** degrees Celsius with no controlled humidity condition. Furthermore, you have no ongoing stability studies for any drugs currently manufactured.

Passage 4

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

Passage 5

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.