Altaire Pharmaceuticals, Inc. – FDA Warning Letter, Apr 19, 2019

The FDA issued a Warning Letter to Altaire Pharmaceuticals, FEI 1000119582, following an inspection from March 25 to April 19, 2019, at their Aquebogue, NY facility. The letter details significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Environmental Monitoring System (21 CFR 211.42(c)(10)(iv)):** Serious data integrity breaches were found, with laboratory technicians falsifying environmental and personnel monitoring data. Plates exceeding action limits were not investigated, and "post-activity" personnel monitoring was not conducted for up to a year, despite being recorded as "0." This raises concerns about the integrity of data throughout the operation. 2. **Failure to Establish Adequate Laboratory Controls (21 CFR 211.160(b)):** Laboratory data used for batch release of sterile ophthalmic products was falsified. Required tests, such as the (b)(4) test for sterility media turbidity, were not performed, and products were released despite a lack of accurate sterility analyses. 3. **Improper Gowning Practices (21 CFR 211.28(a)):** Operators performed aseptic operations with exposed skin due to ill-fitting hoods and goggles, and non-individually wrapped gloves were compromised prior to entering aseptic areas.