Frogs, fungus and falsified data - Indian firm falls foul of US FDA

Amanta - formerly known as Marck Biosciences - manufactures a range of ophthalmic and respiratory solutions both for itself and as a contractor from its facility in Kheda in the Gujarat region of India. An inspection in October-November 2013 has landed the firm in hot water with the US Food and Drug Administration (FDA), which observed a number of GMP violations surrounding poor sanitation and data integrity at the site.

“Significant mould growth in the washroom located at the entry to the sterile manufacturing area,”​ was cited in the letter​, while with ceiling of the room, which shares a common mezzanine with the adjacent sterile processing rooms “had been allowed to deteriorate to such an extent that it caved in.”​

Furthermore, dead insects were found in the ‘sample pass through’ room, in close proximity to a sterile filling line, and “dead and decaying frogs were found next to the product exit dock.”​

The FDA has also asked Amanta to provide it with details of an MHRA inspection in December which found fungus growth within a large volume parenteral product manufactured at the facility.

Media Witch-hunt​

Amanta spokesman DC Tak told in-Pharmatechnologist.com the firm has two facilities on site. The 150,000sq ft large parenteral block manufactures products mostly for India and the Asia-Pacific region, but “the US FDA visit was in order to consider an ANDA (Abbreviated New Drug Application) made from [its] small volume parenteral facility.”​

“The problems at the site and observations made were outside of the large parenteral block,”​ he confirmed, adding despite the FDA’s criticism the firm still had GMP approvals from a number of other regulators including the TGA (Australia), the MCC (South Africa), and the NPCB, which are all members of the Pharmaceutical Inspection Convention (PIC).

Tak also told this publication some US media outlets had “unfairly”​ compared Amanta with a number of other Indian drugmakers – including Sun Pharmaceuticals​, Wockhardt​ and Ranbaxy​ – which have been the subject of warning letters and import alerts.

“We don’t understand why we have been added to this list,”​ he said, adding the firm is an Indian drugmaker “victimised as part of a media witch-hunt.”​

Remediation​

Along with sanitation issues, the inspection found issues surrounding documenting data including employees admitting to having “recorded activities in batch records that were not performed,” and the falsification of a number of documents.

Furthermore, records used to record critical data were kept unofficially on scratch paper, and “did not always match the data on the corresponding official batch records,”​ while manufacturing staff were found to lack a combination of education, training, and experience.

The FDA says it expects Amanta to hire a third party data integrity expert as part of a remediation effort, and Tak confirmed to us the company had already brought in a number of outside consultants. Furthermore, he said the company was looking to upgrade the plants as part of an ongoing improvement to its manufacturing operations.