FDA 483 - Indoco Remedies Limited (Plant I) - January 19, 2018

This FDA Form 483 document outlines several observations made during an inspection, indicating deficiencies in the facility's quality control and record-keeping practices.

**Key Observations:**

* **Incomplete Laboratory Records:** Laboratory records lack complete data from tests, examinations, and assays required to ensure compliance with specifications and standards. Electronic records used are not compliant with requirements for trustworthiness, reliability, and equivalence to paper records. * **Inadequate Laboratory Controls:** The facility's laboratory controls do not include scientifically sound and appropriate test procedures to assure drug product conformity to identity, strength, quality, and purity standards. * **Deficient Stability Program:** The written stability program for drug products does not incorporate test intervals based on statistical criteria for each attribute, which is necessary for valid stability estimates. * **Insufficient Reserve Sample Examination:** Reserve samples from representative lots or batches are not visually examined at least annually for deterioration, as required. * **Unwritten/Unfollowed Quality Control Unit Procedures:** The responsibilities and procedures of the quality control unit are not documented in writing and are not fully followed. * **Deficient Batch Records:** Batch production and control records lack documentation of the accomplishment of each significant step in manufacturing, processing, packing, and holding. * **Lack of Labeling Examination Documentation:** There is no documentation of the examination and review of labels and labeling to confirm conformity with established specifications.

These observations highlight significant issues across data integrity,