Neeyaan LLC — FDA 483 Findings

Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

For component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary supplement are met, and limits on contamination to ensure the quality of the dietary supplement.

You did not establish packaging specifications.

Your quality control personnel did not conduct a material review and make a disposition decision when a batch deviated from the master manufacturing record.

Equipment used in the manufacture, processing, packing or holding ofdrug products is not ofappropriate design and of adequate size to facilitate operations for its intended use.

Procedures describing the warehousing ofdrug products are not established and followed.

Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.

Your quality control operations did not include determining whether each finished batch conforms to established product specifications.

You did not establish product specifications for identity.

Your batch production record did not include complete information relating to the production and control of each batch.

You did not conduct appropriate tests or examinations or rely on a certificate of analysis to determine whether components met established specifications.

There is no written testing program designed to assess the stability characteristics of drug products.

Strict control is not exercised over labeling issued for use in drug product labeling operations.

You did not follow written procedures for quality control operations.

Drug products are not stored under appropriate conditions of temperature, humidity and light so that their identity, strength, quality, and purity are not affected.

Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.

You did not establish specifications to ensure that you applied the specified label.

Batch production and control records do not include the specific identification ofeach batch of component and in-process material used for each batch of drug product produced.

Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

Your batch production record did not include all required information.

Buildings used in the manufacturing, processing, packing and holding ofa drug product are not maintained in a good state of repair.

Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding ofa drug product.

Specific identification tests are not conducted on components that have been accepted based on the suppliers report of analysis.

The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented.