Drugs

EyePoint Pharmaceuticals GCMP Violations

A 2/6-2/15 FDA inspection at the EyePoint Pharmaceuticals drug manufacturing facility in Watertown, MA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 7/12 Warning Letter says specific violations were:

failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
failure to establish adequate and follow written procedures for production and process control to assure that drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess; and
failure to establish and follow adequate control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

FDA says the firm’s responses to the inspection observations were inadequate. It recommends that EyePoint retain a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. FDA reminds EyePoint that it sees contractors as extensions of manufacturers and says EyePoint is responsible for the quality of the drugs it produces as a contract facility regardless of any agreements with application sponsors and product owners.

EyePoint was told to correct any violations promptly and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.

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