Drug factory · FDA FEI 1000135215

Dispensing Solutions Inc.

Santa Ana, 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.

Oct 18, 2012 inspection

• Approval and review of procedures 21 CFR 211.100(a)
  Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

May 12, 2010 inspection

• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.