# FDA 483 - Jubilant Generics Limited - February 02, 2024

Source: https://www.globalkeysolutions.net/records/483/jubilant-generics-limited/6ad004cb-73c6-4efc-a572-c595d9c68b24

> FDA 483 for Jubilant Generics Limited on February 02, 2024. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jubilant Generics Limited
- Inspection Date: 2024-02-02
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA Form 483 details multiple observations from an inspection, primarily concerning quality control, investigation procedures, and manufacturing processes.

**Key Violations and Observations:**

*   **Inadequate Investigations:** The firm failed to consistently make written records of investigations into unexplained discrepancies. Specifically, a cleaning verification protocol (PR-CV-22-0021) revealed unknown extraneous peaks during residue testing of swab samples. A deviation investigation (PR# 206993) was opened, but the root cause for out-of-specification (OOS) results for REDACTED residue (PR#212885) was not identified even after Phase 1 and Phase 2 investigations. Two extraneous peaks were attributed to REDACTED and REDACTED via LC-MS, but their presence in cleaning verification swab samples lacked a root cause and corrective actions. Other extraneous peaks remained unidentified. Affected lots (REDACTED and REDACTED) were distributed to the US market. The cleaning verification report (RR-CV-23-0007) failed to mention these deviations or OOS investigations, yet concluded the cleaning procedure was effective. This indicates deficient and unreliable cleaning validation/verification, with inadequate impact assessment and CAPA. Approximately REDACTED batches of REDACTED Tablets USP have been released since January 2022.
*   **Quality Control Unit Deficiencies:** Responsibilities and procedures for the quality control unit were

## Related Documents

- [483 - 2024-02-02](https://www.globalkeysolutions.net/records/483/jubilant-generics-limited/cd07e558-a1b5-46b3-8c1c-fd4afe0b5937)
- [483 - 2018-08-08](https://www.globalkeysolutions.net/records/483/jubilant-generics-limited/b9896784-4fab-4e77-ab8d-aae51c611789)
- [483 - 2021-03-12](https://www.globalkeysolutions.net/records/483/jubilant-generics-limited/9219a412-4212-46d1-a2bb-940877604df2)
- [483 - 2021-03-12](https://www.globalkeysolutions.net/records/483/jubilant-generics-limited/67003c16-ec1c-4768-8d71-d52ed40b5c21)
- [WARNING_LETTER - 2018-08-08](https://www.globalkeysolutions.net/records/warning_letter/jubilant-generics-limited/78b01487-1252-4946-a390-b1bd324069c9)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.globalkeysolutions.net/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

Company: https://www.globalkeysolutions.net/companies/jubilant-generics-limited/0e33a821-8bc0-4f36-9264-5a108f087380

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6