Drug factory · FDA FEI 3013061208

Evaric Pharmaceuticals Inc

155 COMMERCE DR, Hauppauge, NY, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

May 16, 2025 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which 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.
• Defined areas of adequate size for operations 21 CFR 211.42(c)
  The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Systems in place to comply with verification requirements FDCA 582(b)(4)
  Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.

Registered with FDA for: analysis; label; manufacture; pack.