Drug factory · FDA FEI 3006978448

California Pharmaceuticals LLC

Camarillo, California, United States

Matched to FDA's records by company name, because this plant's registration on the label has expired.

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Dec 12, 2018 inspection

• Failure to develop written procedures 21 CFR 310.305(a)
  Written procedures have not been developed for the surveillance, receipt, evaluation and reporting to FDA of postmarketing adverse drug experiences.

Mar 23, 2018 inspection

• Adequate number of batches on stability 21 CFR 211.166(b)
  An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
• Approve or reject components, products 21 CFR 211.22(a)
  The quality control unit lacks the responsibility and authority to approve and reject all drug products.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Sep 6, 2013 inspection

• Storage under appropriate conditions 21 CFR 211.142(b)
  Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components, in-process materials, and drug products conform to appropriate standards of identity, strength, quality and purity.
• Drug products - samples representative, identified properly 21 CFR 211.160(b)(3)
  Samples taken of drug products for determination of conformance to written specifications are not representative.
• Tentative expiration date 21 CFR 211.166(b)
  Where data from accelerated studies was used to project a tentative expiration date beyond a date supported by actual shelf life studies, there were no drug product testing at appropriate intervals conducted until the tentative expiration date was verified or the appropriate expiration date determined.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration of automatic, mechanical, and electronic equipment is not performed according to a written program designed to assure proper performance.
• Representative Samples Criteria 21 CFR 211.84(b)
  The amount of material taken from each container is not based upon appropriate criteria.