The FDA issued Kath Khemicals a Form 483 after an inspection of its Sterling Heights, Michigan facility revealed problems with batch reviews, product testing and cleaning, among other deficiencies.

Batch records for the firm’s McD Foaming antibacterial hand soap, did not have documentation to support that they were reviewed, yet were approved or released by the quality control unit before distribution. Its batch records also did not include specimens or copies of labeling used in the packaging.

In another example, the firm did not perform a yearly review of each drug product manufactured at the facility, such as its the antibacterial hand soap or antimicrobial handwash, and no documentation supported that they had been reviewed for complaints or checked yearly for signs of deterioration. Also, the firm had no documentation to support final testing of an active ingredient in its soap products.

In addition, the expiration dates of its products lacked documentation to assure the dates were appropriate.

The firm also did not use proper equipment surfaces. Its lid construction for a formulation tank was comprised of reactive and absorptive material, endangering the purity and safety of the drug products that made contact with it. In addition, its foam filling equipment was observed to have dried product build-up.

The facility also lacked employee training documentation for the review period from 2016 to 2017.