FDA 483 - Zhejiang Bangli Medical Products Co., Ltd. - August 17, 2016

The FDA Form 483 documents significant deficiencies at a manufacturing facility, indicating a complete absence of a Quality Unit and its associated responsibilities. Key missing elements include stability programs, reserve sample retention, Master Batch Records, drug product labeling control, line clearance, a Quality Control Laboratory for purity/potency testing, raw material API examination/testing, cleaning validation, equipment cleaning procedures, equipment qualification/maintenance, process validation, deviation/OOS investigation, change control, complaints investigation, and annual product reviews.

Production batch records are incomplete, lacking API batch numbers, drug formulation, excipient details, equipment used, and manufacturing instructions. The firm lacks final disposition decisions for finished drug products, has no quality agreements with customers for specification conformance, and distributes products without assurance of prior testing.

A severe lack of document control is noted, with the firm refusing to provide documentation prior to January 2016 and full distribution information for products exported to the US, including product names, batch numbers, and distribution dates. Distribution procedures are inadequate; the firm labels contract-manufactured products as its own without finished product testing data and refused to provide distribution amounts. Batch records for multiple US-exported products were also withheld.

In-process controls are inadequate, evidenced by co-mingled, unlabeled patches of different sizes and colors in the manufacturing unit, with employees unaware of batch numbering requirements. Drug products are manufactured in insanitary conditions, with lint and residue buildup, including apparent residual API,