FDA 483 - Indoco Remedies Limited - June 04, 2019

This FDA Form 483 document outlines four observations made during an inspection.

**Observation 1** details deficiencies in determining conformance to written specifications for drug products. Specifically, a batch of "Solution" (Batch #) failed the "any other individual impurities" specification during 24-month stability testing (25°C / 40% RH), with a result of % against a NMT % specification. This batch, produced in and expired in 12/18, was tested on 2/22/19, one month and 22 days after its expiration. The stability testing protocol lacked a point to ensure testing upon expiration, providing no assurance of compliance at the expiration date.

**Observation 2** notes that investigations into batch failures to meet specifications did not extend to other batches of the same drug product.

**Observation 3** identifies the absence of a written testing program to assess drug product stability characteristics. The current procedure (QC/016, version #23, effective 1/19) is inadequate because: a) It lacks provisions for testing products in stability studies at their established expiration dates, allowing testing past expiration for 24 or 36-month products. It does not require additional testing points in stability protocols to ensure testing at expiration. b) It does not define timeframes for placing drug product batches into stability chambers or establish a maximum number for loading samples.

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