Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to properly maintain buildings and facilities used in the manufacture of API.
Passage 2You failed to have adequate procedures for cleaning and maintenance of manufacturing equipment. For example, our investigators observed manufacturing equipment labeled as “cleaned” but found with the following deficiencies.
Passage 3Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP.
Passage 4Failure to test the identity of each batch of incoming production material and to appropriately qualify suppliers to rely upon their certificate of analysis.
Passage 5You failed to conduct an identity test on each lot of raw material used in the manufacture of your API. You instead relied on the certificates of analysis (COAs) from your suppliers without adequately qualifying them. You tested **(b)(4)**, received as your primary raw material, for some quality attributes; however, an identity test was not performed before use in manufacturing.
Passage 6Failure to ensure that all specifications and test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality.
Passage 7You failed to adequately test your **(b)(4)** USP **(b)(4)** API per the current USP monograph. For example, you did not conduct testing for “**(b)(4)**” and “**(b)(4)**.” These tests are not required in your API specification. As a result, you distributed lots of **(b)(4)** API to the U.S. market without assurance that they meet the current USP standards. This may also render your **(b)(4)** USP adulterated under section 501(b) of the FD&C Act.
Passage 8You failed to perform an adequate analytical method verification for **(b)(4)** assay. Your protocol did not include an acceptance limit for the verification of the precision (percent relative standard deviation). The verification exercise included a single determination of each test.
Passage 9You failed to ensure that the analytical method used for stability testing of **(b)(4)** USP **(b)(4)** API is suitable for its intended use. For example, you did not perform forced degradation studies to demonstrate that the method is stability-indicating.
Passage 10Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.
Passage 11You failed to adequately validate your **(b)(4)** API manufacturing process. For example, your process validation lacked a scientific rationale for not including the smallest batch size your firm manufactures, a defined sampling plan for each stage, and testing requirements for raw materials used. In addition, your report lacked an evaluation of critical processing parameters results for the validation batches.