The FDA found serious violations at Sun Pharma’s Halol, Gujarat facility in an inspection earlier this month, hitting the company with a Form 483 for issues ranging from data integrity to employee training.
The agency investigators found that the microbiology laboratory lacked controls to prevent manipulation of environmental monitoring data. Unauthorized users were able to modify sample information in the computer system, among other data integrity flaws.
The firm also lacked proper written procedures for visual examinations of finished products. The visual inspection procedure did not define the number of tablets and capsules to inspect and how much time should be spent examining them, the agency said.
The same facility was cited in June for a substandard media fill and unacceptable drug design plans, among other violations.