Maitland Labs of Central Florida
FDA issued a warning letter to Maitland Labs of Central Florida (Orlando, FL), a registered 503B outsourcing facility, following a February 2020 inspection that revealed serious CGMP deficiencies and labeling violations. The facility's compounded sterile drug products — including Nalbuphine HCl 10 mg/mL in 0.2% Saline — were found to be adulterated, misbranded, and marketed as unapproved new drugs, failing to meet the conditions of section 503B necessary for exemptions from FDA approval requirements. Specific violations included failure to investigate batch discrepancies, inadequate stability testing, failure to conduct sterility/pyrogen testing, false ingredient concentration on labels, and incomplete storage/handling instructions. FDA warned that continued non-compliance could result in seizure and injunction, and required a written response within 15 working days.
Flagged claims (2)
store[d] at room temperature (60-80 Fahrenheit)
0.63% citric acid anhydrous
Required actions (3)
Within 15 (fifteen) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address the issues identified.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
Failure to promptly address these issues may result in legal action, including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most pharmacy / compounding sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker