# FDA 483 - Symed Labs Limited (Unit I) - December 06, 2024

Source: https://www.keypedia.com/records/483/symed-labs-limited-unit-i/850416f1-6daf-4bb6-98f8-a757ed48489a

> FDA 483 for Symed Labs Limited (Unit I) on December 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Symed Labs Limited (Unit I)
- Inspection Date: 2024-12-06
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: During an inspection conducted from December 2 to December 6, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Symed Labs Limited (Unit I), an Active Pharmaceutical Ingredient (API) manufacturer located in Gummadidala, Telangana, India. The report, addressed to CEO Mr. Haribabu Bodepudi, outlines two significant observations regarding the firm's adherence to manufacturing quality standards. The first observation highlighted a failure to establish adequate written procedures for production and process controls. Specifically, Symed Labs Limited modified critical process parameters for a drug substance in 2020 without conducting a new process validation study to assess the impact of these changes on commercial manufacturing. Furthermore, a crucial piece of equipment used in a prior process validation study lacked Installation and Operational Qualification before its use. The second observation detailed deficiencies in the written procedures for equipment cleaning and maintenance. The company did not define the maximum number of consecutive batches that could be manufactured before a major equipment cleaning. Additionally, several cleaning validation studies for shared equipment were found inadequate, as they did not account for the worst-case scenario of multiple consecutive batches being produced before a major cleaning. These observations indicate deviations from current Good Manufacturing Practices (GMP) for API manufacturing. Symed Labs Limited is now expected to investigate these findings thoroughly and implement robust corrective and preventive actions to ensure the quality, purity, and strength of its drug substances, and to address the noted procedural shortcomings.

## Related Documents

- [483 - 2024-12-06](https://www.keypedia.com/records/483/symed-labs-limited-unit-i/51086503-a065-4e12-b441-265f2b71778e)

## Related Officers

- [Bijoy Panicker](https://www.keypedia.com/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)
- [Gregory Stone](https://www.keypedia.com/people/gregory-stone/6fc15653-2d1b-46d6-89dd-655a40ea72de)

Company: https://www.keypedia.com/companies/symed-labs-limited-unit-i/6687f07e-a946-4527-86e8-687f0ec46c66

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa