Consolidated Chemical, Inc – FDA 483, May 22, 2008

This FDA Form 483 documents numerous violations at a drug manufacturing facility. The facility released drug products, specifically Techni-care surgical scrub (Chloroxylenol) batches, that failed to meet established specifications without justification. Viscosity specifications for Techni-care surgical scrub were changed without scientific justification, and lots failing the original specification were released.

Key issues include: * **Quality Control Deficiencies:** Laboratory controls lack scientifically sound specifications, standards, sampling plans, and test procedures. Test methods' accuracy, sensitivity, specificity, and reproducibility are not established or documented. The quality control unit lacks the authority to approve/reject materials and products. * **Investigation Failures:** Unexplained discrepancies and batch failures are not thoroughly reviewed, and investigations are not always documented or extended to other potentially affected batches/products. * **Production and Process Control Issues:** Written procedures for production and process controls are absent or not followed, and deviations are not justified. Reprocessing procedures are inadequate. Batch records are incomplete and lack identification of persons checking significant steps. In-process controls and tests are not established or followed. * **Documentation and Change Control:** Changes to written procedures are not properly drafted, reviewed, and approved. Annual evaluations are not conducted. * **Equipment and Facilities:** Equipment and utensils are not cleaned, maintained, or sanitized at appropriate intervals, and written procedures for cleaning/maintenance are lacking. Adequate lighting is not provided. * **