Hospira, already dealing with FDA problems at two plants in India, has bought itself some more issues with the FDA. About three months before Hospira closed on its acquisition of an active pharmaceutical ingredient (API) plant from India's Orchid Chemicals & Pharmaceuticals, FDA inspectors made a visit to the facility in Waluj. They had concerns with what they found.
|Hospira CEO F. Michael Ball|
According to The Financial Express, which reviewed the documents, an April 25 Form 483 had 7 observations, including concerns about whether Orchid's testing of APIs and intermediates was good enough to insure they met quality and purity standards. Inspectors also said Orchid's cleaning and sanitation of equipment was inadequate to keep APIs from getting contaminated.
In July, Hospira said it had completed the $218 million acquisition of the 538,196-square-foot API manufacturing facility which Orchid built in 2000. The deal also included an associated research and development (R&D) facility in Chennai, India, and the nearly 800 employees which work at the two facilities. The plant, which manufactures beta-lactam antibiotic products, was already supplying Hospira when it struck the deal in 2012. Hospira in 2009 had bought Orchid's generic injectable for about $400 million.
Hospira is already dealing with a host of issues at two other plants in India. A facility in Irungattukottai was tagged with a warning letter in May 2013 and then received another 23 observations in a follow-up inspection last December. Earlier this year, Hospira CEO F. Michael Ball told analysts that after a preapproval inspection of a plant it is building in Vizag, India, the FDA issued a Form 483 with 10 observations.
- here's the Financial Express story