FDA raises cleaning and quality concerns at another Ipca Laboratories manufacturing site in India

In­di­an man­u­fac­tur­er Ip­ca Lab­o­ra­to­ries has an­oth­er pro­duc­tion site un­der the FDA’s mi­cro­scope af­ter an in­spec­tion re­vealed sev­er­al qual­i­ty is­sues.

The FDA iden­ti­fied eight over­ar­ch­ing is­sues at the man­u­fac­tur­ing site in Dhar, In­dia, which was in­spect­ed be­tween June 15 and June 23.

The 18-page re­port found that equip­ment and uten­sils were not be­ing main­tained prop­er­ly or cleaned to pre­vent con­t­a­m­i­na­tion. Specif­i­cal­ly, “sig­nif­i­cant scratch­es” and dents were found on one piece of equip­ment, while an­oth­er was re­port­ed to have some un­known residue buildup and ap­peared clogged at var­i­ous lo­ca­tions.

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