Glossary
Contract Manufacturer
A manufacturer performing some or all of the manufacturing operations on behalf of another manufacturer under a written contract.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Inadequate Design of Facility and Equipment Your firm is a contract manufacturer of sterile injectable drug products produced primarily through aseptic processing including, but not limited to, products for (b)(4) use…
FDA · FDA Warning Letter · 2026-04-21 -
Your firm is a contract manufacturer of over-the-counter (OTC) (b)(4) drug products.
FDA · FDA Warning Letter · 2026-02-03 -
Your firm is a contract manufacturer of over-the-counter (OTC) drug products, including oral cough and cold drug products marketed for both adults and children.
FDA · FDA Warning Letter · 2023-12-26
