Antaria Pty. Ltd.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to adequately investigate and document out-of-specification results and implement appropriate corrective actions.

Passage 2

Failure to ensure that, for each batch of API, appropriate laboratory tests are conducted to determine conformance to specifications.

Passage 3

Failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure your API complies with established specifications and standards.

Passage 4

You failed to include complete data in your laboratory records for all laboratory analyses, and accordingly relied on incomplete information to determine whether your **(b)(4)** USP met established specifications. For example, you lacked documentation of the preparation of stock solutions, sample solutions, diluents, mobile phases, and reagents used during testing of your API. You also failed to document the instruments and equipment used when performing analytical testing.

Passage 5

Failure to design an adequate documented, on-going stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates.