FDA 483 - Galaxy Surfactants Limited - March 23, 2018

On March 23, 2018, an FDA inspection of Galaxy Surfactants Ltd. in Tarapur, India, resulted in a Form 483 with three observations.

Observation 1 noted that procedures designed to prevent microbiological contamination of drug products purporting to be sterile were not established and followed. Specifically, the firm manufactures an Active Pharmaceutical Ingredient (API) that is terminally sterilized and labeled as sterile. However, the firm lacks a robust program to monitor environmental conditions in the manufacturing area where the API is exposed to the environment prior to sterilization. This includes a lack of routine viable and non-viable particulate monitoring.

Observation 2 identified that equipment and utensils were not cleaned and maintained at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, and purity of the drug product. The firm uses a multi-product facility where the same equipment is used to manufacture both drug and non-drug products. The cleaning validation for the shared equipment was found to be inadequate.

Observation 3 stated that there is a failure to thoroughly investigate any unexplained discrepancy or the failure of a batch or any of its components to meet specifications, whether or not the batch has been already distributed. The firm failed to adequately investigate out-of-specification (OOS) results for bioburden and endotoxin during stability testing of the API. The investigations were closed without a conclusive root cause identified.