FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Indian API Manufacturer Cited for Complaint Handling, Batch Records

Dec. 13, 2018

The FDA hit Vital Laboratories with a Form 483 for incomplete batch production records, inadequate complaint handling and unapproved labeling, among other violations, at its Vapi, Gujarat facility.

The investigator, who inspected the facility between Aug. 28 and Sept. 1, noted that the firm was missing required information from four batch production records — a repeat observation from a previous inspection. The missing information included signatures, completion dates and equipment inspection dates, as well as information on raw materials and incomplete impurity profiles.

Complaints were not fully investigated and documented, the inspector found. For example, the facility did not conduct a root cause analysis for one recorded complaint. Another complaint, involving black particles found in a material, was not investigated to determine the source of the particles.

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