The US health regulator has issued warning letter to Bangalore-based Sutures India, a manufacturer and exporter of surgical sutures, for non-compliance of manufacturing standards.
The warning by the US Food and Drug Administration (USFDA) was issued after an inspection of the firm held from April 19-23, the USFDA said in its website.
"...The methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation...," the USFDA said in its letter.
Comments from the company could not be be obtained immediately.
In its warning letter, the health regulator highlighted as many as six main violations of norms by Sutures India.
The USFDA said the company failed to establish and maintain adequate procedures to control the design of the device in order to ensure that specified design requirements are met.
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It also accused the company of failing to "establish and maintain adequate procedures to control all documents and provide for document approval and distribution by designating an individual to review for adequacy and approve prior to issuance all documents established to meet the requirements..."
The USFDA also pointed out that the company did not maintain adequate device master records (DMRs) for each type of device that include or refer to the location of quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used.
As per information available on its website, Sutures India manufactures absorbable and non-absorbable sutures, surgical tapes, skin staple and surgical needles among many other items.
Its products are exported to over 50 countries in Europe, South America, Africa and Asia.