# FDA 483 - Symbiotec Pharmalab Limited - July 05, 2019

Source: https://www.globalkeysolutions.net/records/483/symbiotec-pharmalab-limited/cf088f34-f895-4163-8a40-240a14d6440a

> FDA 483 for Symbiotec Pharmalab Limited on July 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Symbiotec Pharmalab Limited
- Inspection Date: 2019-07-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Symbiotec Pharmalab Private Limited, an API manufacturer in Pithampur, Madhya Pradesh, India, was cited for significant deficiencies across its quality control and manufacturing operations. The inspection revealed failures in laboratory investigations for out-of-specification results, inadequate monitoring of critical process parameters, and deficiencies in cleaning validation master plans. Additionally, the firm was found to have inadequately performed equipment and production process qualifications and validations, including a lack of stability monitoring for API lots.

## Related Documents

- [483 - 2017-05-05](https://www.globalkeysolutions.net/records/483/symbiotec-pharmalab-limited/b2c4cdff-0b5d-4ee1-9cf1-cdab635f6651)
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- [483 - 2022-09-30](https://www.globalkeysolutions.net/records/483/symbiotec-pharmalab-limited/4e3aad04-a511-45b9-a863-c5458474221b)

## Related Officers

- [Christopher S. Keating](https://www.globalkeysolutions.net/people/christopher-s-keating/94fcfd32-feb5-4b6c-80da-16202f4be01d)
- [Ralph H. Vocque](https://www.globalkeysolutions.net/people/ralph-h-vocque/dfd4e4f2-b03d-44ec-9dd7-7edcee303356)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1