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Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S.
FDA establishment 3004135088, Cekmekoy, Turkey. Part of Tan-Alize Kozmetick ve Temizlik Urunleri Sanayi ve Ticaret A.S.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
Inspections: 2
Official action indicated: 1
Last inspection ended: Feb 27, 2026
Warning letters: 2
Import refusals since 2024: 41
Import refusals 2014 to 2023: 55, first Aug 4, 2023
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
21 CFR 211.160(b)(2). Acceptance of in-process materials Determinations of conformance to appropriate written specifications for acceptance are deficient for in-process materials.
21 CFR 211.188. Prepared for each batch, include complete information Batch production and control records do not include complete information relating to the production and control of each batch.
21 CFR 211.46(c). Air filtration system lacking in production area The production area air supply lacks an appropriate air filtration system.
21 CFR 211.113(a). Procedures for non-sterile drug products Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that components, drug product containers and drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
Official Action Indicated (OAI)
May 17, 2024
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Warning Letters
Letters naming this establishment; each opens the letter
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
Cekmekoy, Turkey. Part of