Inventia Healthcare, a drugmaker headquartered in Mumbai, India, was slapped with a Form 483 for serious violations at its Thane, Maharashtra facility, including poor data integrity.
The agency took issue with the firm’s access controls for its chromatography data. Specifically, the quality assurance department, outside service personnel roles and authorization responsibilities were not included in its chromatography system standard operating procedure for data access, user privileges, electronic signatures and system policies.
The FDA also flagged issues with the company’s laboratory records, noting that a “significant number” of balance and pH meter data printouts were incomplete. For example, they did not include the date they were signed by the analyst and reviewer and lacked sample numbers or test references.