# FDA 483 - Shilpa Pharma Lifesciences Limited - January 19, 2018

Source: https://www.globalkeysolutions.net/records/483/shilpa-pharma-lifesciences-limited/45380c3a-962d-4d61-a65a-9b306068fc0d

> FDA 483 for Shilpa Pharma Lifesciences Limited on January 19, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shilpa Pharma Lifesciences Limited
- Inspection Date: 2018-01-19
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details observations from an inspection of a facility manufacturing Intermediates and APIs.

Observation 1, a repeat finding, notes that equipment and utensils are not adequately cleaned and maintained to prevent contamination. On January 16-17, 2018, discoloration resembling rust was observed inside Equipment ID: 25 in Unit 1, a non-dedicated piece of equipment marked as "cleaned" and used in drug product manufacturing since July 2017. In Unit 2, discoloration resembling rust was seen inside Equipment ID: 12, also a non-dedicated, "cleaned" piece of equipment, with visible residue alongside the agitator. The firm had not investigated potential contamination of drug products manufactured in this equipment. Additionally, in Room 11, a torn filter bag exposed what appeared to be rust or corrosion, and a gasket protecting the filter and filter housing was wrapped in tape.

Observation 2 states that the firm’s environmental monitoring sampling plan is not clearly defined and does not represent worst-case activities and conditions. Specifically, in the (b)(4) area used for (b)(4) API production, non-viable air samples are not performed under dynamic conditions, and surface samples are not representative of the most critical locations.

Observation 3 indicates that extractable and leachable studies for the (b)(4) bags (b)(4) used in the packaging of (b)(4

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## Related Officers

- [June P. Page](https://www.globalkeysolutions.net/people/june-p-page/3b1ffc71-ce2e-47f5-aefe-87fd5eebc792)

Company: https://www.globalkeysolutions.net/companies/shilpa-pharma-lifesciences-limited/4f617c67-eea7-483d-b9c7-b1dd31aabcff

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