Institute of Good Manufacturing Practices India®

Haw Par Healthcare Limited receives USFDA warning letter

USFDA inspection was done at Haw Par Healthcare Limited drug manufacturing facility located at Singapore, from February 25 to March 1, 2019.

Issued warning letter summarized the significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Reasons for the letter are the methods, facilities, or manufacturing control, processing, packing, or holding which are not in compliance to CGMP, drug products were modified with respect to section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

Specific CGMP violations were observed by the inspector which are as follows:

  1.  Failure of the firm in thoroughly investigating any unexplained discrepancy or failure of a batch.
  2.  Failure of the firm in establishing laboratory controls that including scientifically sound and appropriate specifications along with sampling etc.
  3.  Failure of the firm in ensuring that laboratory records included complete data derived from all tests.
  4.  Failure of the firm in using equipment in the processing, manufacturing, packing, or holding of drug products that is of proper design, adequate size, and located suitably to facilitate operations.