The FDA published only seven warning letters this week. Of interest to us are two issued to finished drug manufacturers. The FDA continues their focus on OTC facilities that seemed to begin in 2017.
- Polaroisin International Co., Ltd. (Taiwan) received a warning letter on January 25, 2018, based on the outcome of an inspection ending September 15, 2017. FDA placed the firm on Import Alert 66-40 on January 8, 2018. FDA recommends that they employ a consultant to assist them in coming into compliance with the regulations. This enforcement action represents another site that manufactures OTC drugs, an area where FDA began to focus in 2017. Deficiencies include but are not limited to:
- The firm released product without testing for the identity or strength of the active ingredient.
- The firm did not test incoming raw materials and components, including APIs, to ensure they meet appropriate acceptance criteria. The firm also does not have a vendor qualification program.
- The firm does not have stability data to support expiry dating. They are in discussions with their contract laboratory about this activity.
- The firm has not validated the manufacturing process for their OTC drugs nor do they have an ongoing control monitoring program.
- Celltrion Inc. (South Korea) received a warning letter on January 26, 2018, based on the outcome of an inspection ending June 2, 2017. FDA posted the 10-page form 483 for that inspection. FDA recommends the firm employ a qualified consultant to assist them in coming into compliance with GMPs. Justin Boyd was the single FDA investigator for the inspection. Fierce Pharma reports that the firm manufactures biosimilars for Pfizer. Deficiencies include but are not limited to:
- Deficiency #1 addresses poor aseptic practices. The FDA cites a list of activities that the firm must remediate. Also, they identified areas where they observed problems including smoke studies and media fills. LOTS of detail here.
- The firm failed to adequately investigate deviations. One, in particular, appears to be a failure to investigate visible particles in vials of parenteral product. The redaction here is thorough (deficiency #2), but some of the accompanying text addresses particles. The firm uses a contract laboratory for at least some visible particle examination. See observation #1 in the 483 for additional detail.
- The environmental monitoring program is deficient. The firm does not perform active air monitoring in ISO 5 areas during operation.
- It’s interesting that the warning letter did not include the multiple ‘data integrity’ type observations that identified failure to document data contemporaneous with its collection, common user names and passwords for selected laboratory systems, failure to review audit trails, and discarding/deleting failing filter integrity testing data.
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