Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your firm failed to establish an adequate quality control unit, and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)).
Passage 2Your firm failed to prepare batch production and control records that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188(b)).
Passage 3Your 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, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).
Passage 4Your firm failed to adequately qualify the equipment and validate the processes used to manufacture your drug products. You have not performed process performance qualification (PPQ) studies, nor do you have an ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality for products in U.S. distribution.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.10(c)(4)
- 21 CFR 201.128
- 21 CFR 201.66(b)(2)
- 21 CFR 201.66
- 21 CFR 207.77(a)
- 21 CFR 210.3(b)(7)
- 21 CFR 210.3(b)(8)
- 21 CFR 210
- 21 CFR 211.22(a)
- 21 CFR 211.188(b)
- 21 CFR 211.100(a)
- 21 CFR 314.3(b)
- 21 CFR 330.1(e)
- 21 CFR 330