FDA WARNING_LETTER - Maitland Labs of Central Florida - February 28, 2020

The FDA issued a Warning Letter to Maitland Labs of Central Florida following an inspection from February 19-28, 2020. The facility, registered as an outsourcing facility under section 503B of the FDCA, was found to have produced drug products that failed to meet 503B conditions and exhibited serious deficiencies in sterile drug production, posing patient risks.

Violations include: - **Failure to meet 503B conditions:** Drug product labels lacked established names and dosage forms (e.g., Nalbuphine 10 mg/mL in 0.2% Saline), and container labels omitted active/inactive ingredients and quantities. The facility also failed to comply with adverse event reporting requirements, with inadequate procedures for record retention and submission methods. - **Adulterated drug products (CGMP violations):** Failure to investigate unexplained discrepancies (21 CFR 211.192), establish adequate stability testing programs (21 CFR 211.166(a)), and conduct laboratory testing for sterility and pyrogenicity (21 CFR 211.167(a)). - **Unapproved new drug products:** No FDA-approved applications for compounded drugs, violating sections 505(a) and 301(d) of the FDCA. - **Misbranded drug products:** Labeling lacked adequate directions for use (section 50