# FDA 483 - Jindal Drugs Private Limited - March 22, 2024

Source: https://www.keypedia.com/records/483/jindal-drugs-private-limited/ef91c6ff-041f-4c53-9885-70c99da1840a

> FDA 483 for Jindal Drugs Private Limited on March 22, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jindal Drugs Private Limited
- Inspection Date: 2024-03-22
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: During an FDA inspection conducted from March 18-22, 2024, Jindal Drugs Private Limited in Navi Mumbai, India, received a Form 483 detailing significant observations concerning its Active Pharmaceutical Ingredient (API) manufacturing. The inspection identified critical shortcomings across several areas. The firm failed to maintain adequate facilities and cleaning procedures, exemplified by the use of unvalidated hand soap and hot water for laboratory equipment and general cleaning, lacking scientific justification. Storage conditions were also found to be unsuitable, with warehouse temperatures consistently high and product labels omitting vital storage instructions for products shipped to the U.S.

Serious deficiencies were observed in the water purification system, including equipment leaks, potential microbial growth sources, and the detection of pathogens in soft water used for cleaning, without proper investigation. Additionally, the company deviated from established test procedures for in-process materials, and critical analytical instrumentation, such as a refrigerator for standards, was unqualified. Cleaning validation processes were inadequate, and the system for evaluating critical raw material suppliers was found to be insufficient. These observations signify non-compliance with current Good Manufacturing Practices (GMP) and mandate comprehensive corrective and preventive actions from Jindal Drugs Private Limited to ensure product quality and safety.

## Related Documents

- [483 - 2024-03-22](https://www.keypedia.com/records/483/jindal-drugs-private-limited/3ae51157-cfec-4e2a-8315-de597240c17d)

## Related Officers

- [Investigator](https://www.keypedia.com/people/clinton-j-lott/ac4c7d18-13fd-4b1b-b2a1-06794c9960c7)

Company: https://www.keypedia.com/companies/jindal-drugs-private-limited/8f37471f-abb8-4726-a891-0b504e104476

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa