Optikem International Inc.
FDA issued a warning letter to Optikem International Inc., a contract manufacturer of sterile OTC and homeopathic ophthalmic drug products in Denver, CO, citing significant CGMP violations found during a January 2024 inspection. Violations included inadequate aseptic processing facility design, insufficient environmental and personnel monitoring, lack of process simulation (media fills), failure to validate manufacturing and water systems, inadequate laboratory controls, and data integrity deficiencies. FDA also noted that certain ophthalmic drug products manufactured by Optikem are considered unapproved new drugs, and warned that failure to remediate could result in seizure, injunction, and withholding of export certificates or new application approvals.
Flagged claims (1)
we consider ophthalmic drug products manufactured by Optikem for (b)(4) to be unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).
Required actions (4)
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market.
A commitment to have a qualified consultant conduct extensive annual audits, for at least 2 years, to assist in evaluating CAPA effectiveness after you have executed your data integrity remediation protocol.
Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice 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