# FDA 483 - Dr. Reddy's Laboratories Limited (Unit II) - July 12, 2019

Source: https://www.keypedia.com/records/483/dr-reddys-laboratories-limited-unit-ii/4421091a-cc87-4530-9c0a-5a5de54b12e9

> FDA 483 for Dr. Reddy's Laboratories Limited (Unit II) on July 12, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Reddy's Laboratories Limited (Unit II)
- Inspection Date: 2019-07-12
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA Form 483 details five observations from an inspection. The facility's investigations into product complaints and out-of-specification (OOS) QC analytical results for finished API products are inadequate. Customer complaints and retention sample retesting confirmed OOS results (low assay, microbiological failures, high water content/loss on drying), but root causes were not determined, and returned material was reprocessed without adequate conclusion. Humidity's impact on finished APIs and retention samples, stored in uncontrolled areas, was not evaluated, despite confirmed OOS failures for water content linked to high humidity in the QC laboratory, which shares environmental conditions with storage areas. Alert/action levels for humidity are not established.

Preventative controls for the electronic inventory and warehousing management systems are ineffective. The SAP system was not adequately qualified/validated per ICH and Part 11, lacking negative challenges to prevent product mix-ups. Multiple complaints confirm incorrect API shipments. The barcode scanner is deficient, losing connection in cold storage, causing raw material containers to disappear from the SAP database, and unable to differentiate between raw materials from different manufacturers using the same SAP code.

Materials are not stored under appropriate conditions according to manufacturer specifications. Raw materials were observed in extreme heat and humidity (exceeding 45°C and 80% RH in Warehouses 1, 3, 7) and open areas, despite requirements for protection from moisture/oxygen, potentially affecting quality, purity, and potency.

## Related Documents

- [WARNING_LETTER - 2015-03-06](https://www.keypedia.com/records/warning_letter/dr-reddys-laboratories-limited-unit-ii/f32ac88e-3d0e-492c-96bf-fc45be17856f)
- [483 - 2019-07-12](https://www.keypedia.com/records/483/dr-reddys-laboratories-limited-unit-ii/e127be34-a78b-472b-9cf1-761fe9d12d59)
- [483 - 2024-11-19](https://www.keypedia.com/records/483/dr-reddys-laboratories-limited-unit-ii/270586ef-e74d-41e1-95e3-04a843954efa)

## Related Officers

- [Christopher S. Keating](https://www.keypedia.com/people/christopher-s-keating/94fcfd32-feb5-4b6c-80da-16202f4be01d)
- [Ralph H. Vocque](https://www.keypedia.com/people/ralph-h-vocque/dfd4e4f2-b03d-44ec-9dd7-7edcee303356)

Company: https://www.keypedia.com/companies/dr-reddys-laboratories-limited-unit-ii/8017cea4-be8d-4551-8eb7-f0f8cf4509da

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