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Unichem Laboratories FDA-483
09/13/2018
 

FDA has released the FDA-483 issued following a 7/23-7/27 inspection at Unichem Laboratories, Pithampur, Dhar, India. Specific observations at the drug manufacturing firm were: 

  •          cleaning procedures are not validated;
  •          test procedures are not scientifically sound and appropriate to ensure that raw materials, intermediates, APIs, and labels and packaging materials conform to established standards of quality and/or purity;
  •          laboratory controls were not followed and documented at the time of performance; and
  •          there was no record of stability samples stored in containers that simulate the market container.


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