# FDA 483 - Symbiotec Pharmalab Limited - May 05, 2017

Source: https://www.keypedia.com/records/483/symbiotec-pharmalab-limited/0c21bfeb-cc25-424f-b0e2-80e6cf079a94

> FDA 483 for Symbiotec Pharmalab Limited on May 05, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Symbiotec Pharmalab Limited
- Inspection Date: 2017-05-05
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Symbiotec Pharmalab Private Limited in Pithampur, India, received a Form 483 with six observations following an inspection. The inspection revealed significant issues including missing critical records, discrepancies between documented GMP work and employee presence, and the use of an invalid test method in an API stability program. Additionally, the firm failed to conduct a full risk assessment for computer system validation, did not perform required supplier requalifications, and used an unqualified test device for packaging material release.

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## Related Officers

- [Satheesh Thomas](https://www.keypedia.com/people/satheesh-thomas/8009b8a5-40f5-4791-b0e9-a7c855e3afd4)

Company: https://www.keypedia.com/companies/symbiotec-pharmalab-limited/70a966a5-ef02-46b0-8e2a-8a953f473496

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8