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

Source: https://www.keypedia.com/records/483/symbiotec-pharmalab-limited/b2c4cdff-0b5d-4ee1-9cf1-cdab635f6651

> 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: Center for Drug Evaluation and Research
- Summary: An FDA Form 483 was issued to Symbiotec Pharmalab Private Limited following an inspection conducted from May 1-5, 2017. The inspection identified several significant deviations from good manufacturing practices at the API manufacturing facility in Pithampur, India. Key observations included a pervasive issue with recordkeeping, where various essential documents such as retest packaging material logbooks, in-process sample logbooks, and raw material protocol issuance logs for 2016 were either missing or unavailable for review. Furthermore, the inspection uncovered serious data integrity concerns, as biometric system records contradicted GMP documentation, showing that employees who reportedly performed critical GMP-related work, training, or temperature monitoring were not present on site at the documented times. Additional violations involved the use of an invalid chromatographic purity test method for an intermediate, which affected the stability program of an API intended for the U.S. market. The firm also failed to conduct a full risk assessment for its computer system validation to demonstrate compliance with 21 CFR Part 11. Supplier requalification, a critical aspect of quality assurance, was not performed as required by the firm's own standard operating procedures for key starting material suppliers. Lastly, a test apparatus used for verifying pinholes in primary packaging material for U.S.-bound APIs was found to be unqualified. Symbiotec Pharmalab Private Limited is required to respond to these observations with detailed corrective and preventive actions to ensure compliance with regulatory standards.

## Related Documents

- [483 - 2017-05-05](https://www.keypedia.com/records/483/symbiotec-pharmalab-limited/f23cd29b-fb3a-440e-a7b2-bf0e571050b0)
- [483 - 2017-05-05](https://www.keypedia.com/records/483/symbiotec-pharmalab-limited/0c21bfeb-cc25-424f-b0e2-80e6cf079a94)
- [483 - 2019-07-05](https://www.keypedia.com/records/483/symbiotec-pharmalab-limited/cf088f34-f895-4163-8a40-240a14d6440a)
- [483 - 2022-09-30](https://www.keypedia.com/records/483/symbiotec-pharmalab-limited/4e3aad04-a511-45b9-a863-c5458474221b)

## Related Officers

- [Satheesh Thomas](https://www.keypedia.com/people/satheesh-thomas/8009b8a5-40f5-4791-b0e9-a7c855e3afd4)
- [Managing Director](https://www.keypedia.com/people/anil-satwani/e524015b-5073-413a-b8bd-c1c5ce457514)

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

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