# FDA WARNING_LETTER - Ranbaxy Laboratories, Ltd., Dewas, India - February 12, 2008

Source: https://www.keypedia.com/records/warning_letter/ranbaxy-laboratories-ltd-dewas-india/30639130-5fd3-4818-89cf-acc5bc3ccc41

> FDA WARNING_LETTER for Ranbaxy Laboratories, Ltd., Dewas, India on February 12, 2008. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Ranbaxy Laboratories, Ltd., Dewas, India
- Inspection Date: 2008-02-12
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Warning Letter, dated September 16, 2008, was issued to Ranbaxy Laboratories, Ltd., Dewas, India, following an inspection from January 28 - February 12, 2008. The inspection revealed significant deviations from U.S. current Good Manufacturing Practice (CGMP) Regulations (21 CFR Parts 210 and 211) for sterile and non-sterile finished products, and violations of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act for Active Pharmaceutical Ingredients (APIs).

Key violations include:
1.  **Inadequate Beta-Lactam Containment Program:** Failure to establish separate areas for non-penicillin beta-lactam products, observed inadequate containment practices (personnel/material movement, record handling), and insufficient decontamination procedures and monitoring programs (lack of testing for penem, penicillin, and cephalosporin residues in various blocks, and no contingency plans for contamination).
2.  **Incomplete Batch Production and Control Records:** Records lacked documentation of excipient weights/measures and second-person verification for non-sterile products, and incomplete information for sterile media fill batches (operator initials, visual inspection, integrity tests).
3.  **Inadequate Failure Investigations:** Sterility failures for four sterile API batches were inadequately investigated (root cause not confirmed, inaccurate reporting, environmental/personnel monitoring data

## Related Officers

- [Director](https://www.keypedia.com/people/richard-l-friedman/2827edf4-7dbd-4430-96b2-87853c27e113)
- [Dr.](https://www.keypedia.com/people/tg-chandrashekhar/b92b05e7-c2ec-4a82-a19a-59488846955d)

Company: https://www.keypedia.com/companies/ranbaxy-laboratories-ltd-dewas-india/17ee0c9b-4da9-4c59-a5d9-c2d1e166f7e8

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