# Symbiotec Pharmalab Private Limited – FDA 483

Source: https://www.keypedia.com/records/483/symbiotec-pharmalab-private-limited/ff2a262b-21f0-436b-aad2-052582b2df8f

> FDA 483 for Symbiotec Pharmalab Private Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Symbiotec Pharmalab Private Limited
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Synbiotec Pharmalab Limited, a drug substance manufacturer in Indore, India, revealed significant deficiencies in manufacturing controls and quality systems. Observations included inadequate in-process checks for drug substance manufacturing, insufficient equipment requalification, and poor equipment maintenance. Additionally, the firm failed to establish criteria for CAPA effectiveness checks.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

Company: https://www.keypedia.com/companies/symbiotec-pharmalab-private-limited/5896f4c4-d7d7-477e-9084-dec79ec7f905

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3