# FDA 483 - Divi's Laboratories Ltd. (Unit II) - September 19, 2017

Source: https://www.globalkeysolutions.net/records/483/divis-laboratories-ltd-unit-ii/85a9b4a5-0956-4d81-8d9f-f4a55c288d6b

> FDA 483 for Divi's Laboratories Ltd. (Unit II) on September 19, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Divi's Laboratories Ltd. (Unit II)
- Inspection Date: 2017-09-19
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: Divi's Laboratories Ltd., Unit II, located in Visakhapatnam, India, underwent an FDA inspection from June 29 to July 5, 2017. The inspection resulted in a Form 483 with three observations.

Observation 1 notes that the firm's quality control unit failed to ensure that drug products manufactured at the facility met the identity, strength, quality, and purity characteristics they purported or were represented to possess. Specifically, the firm released Active Pharmaceutical Ingredients (APIs) that were reprocessed multiple times without adequate justification or evaluation of the impact on the final product quality. There was no scientific rationale provided for the number of reprocessing steps, and the firm did not establish limits for the number of times a batch could be reprocessed. This indicates a lack of robust process control and validation.

Observation 2 identifies that the firm's quality unit responsibilities and procedures were not fully followed. The quality unit failed to adequately investigate out-of-specification (OOS) results and deviations. For instance, investigations into OOS results for impurities in certain APIs were closed without identifying a root cause or implementing effective corrective and preventive actions (CAPAs). This suggests a deficiency in the firm's deviation management and OOS investigation processes, potentially leading to the release of non-conforming products.

Observation 3 states that the firm failed to establish and follow adequate written procedures for production and process control designed to assure that the drug products have

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## Related Officers

- [Compliance Officer / Investigator](https://www.globalkeysolutions.net/people/erika-v-butler/3e654530-4c29-403d-880e-a5422315c3c0)

Company: https://www.globalkeysolutions.net/companies/divis-laboratories-ltd-unit-ii/b2498cb9-d277-498a-b32b-037e04f6feaf

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c