# FDA 483 - Indoco Remedies Limited (Plant I) - January 25, 2019

Source: https://www.globalkeysolutions.net/records/483/indoco-remedies-limited-plant-i/e2568f3f-606a-4a92-be51-5e4b7b0664a6

> FDA 483 for Indoco Remedies Limited (Plant I) on January 25, 2019. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Indoco Remedies Limited (Plant I)
- Inspection Date: 2019-01-25
- Product Type: Devices
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: The FDA Form 483 details significant quality system and manufacturing deficiencies at a pharmaceutical facility. Investigation DEV-18-033 revealed that production and IPQA personnel deliberately recorded inaccurate compression force values for tablet batches, which did not match electronic machine data. This investigation was deemed incomplete, failing to identify the cause of variability in compression force and filling weight, and lacking assurance that automatic weight controls (AWC) were properly utilized. Numerous discrepancies between PLC/balance printouts and batch records were noted, including AWC being off while recorded as on, machine malfunction without documentation, and unverified changes to filling parameters.

Further issues include:
- **Investigation OOS-18-236:** An out-of-specification (OOS) assay result was attributed to sampling error without supporting data, and resampling occurred without an approved protocol.
- **Investigation OOS-18-108:** A stability failure for appearance was concluded as "expected" without supporting data.
- **Laboratory Records:** Incomplete data, unreported OOS results from Karl Fischer and Autotitrator instruments, and lack of original weight printouts were observed.
- **Data Integrity:** Original electronic chromatograms were not maintained after reprocessing, and production personnel's weight checks between required in-process checks were not recorded.
- **Batch Records:** Incomplete information, with individuals listed as "Done By" not performing or recording all tests, and master production record procedures lacking

## Related Documents

- [483 - 2018-01-19](https://www.globalkeysolutions.net/records/483/indoco-remedies-limited-plant-i/e01a0020-afb5-43b8-b1f0-6186bcc2c7dc)
- [483 - 2019-01-25](https://www.globalkeysolutions.net/records/483/indoco-remedies-limited-plant-i/6817f714-58eb-49a0-bd22-621d560a785e)
- [483 - 2023-01-20](https://www.globalkeysolutions.net/records/483/indoco-remedies-limited-plant-i/98381d61-704e-465e-8453-c84dc8652416)
- [483 - 2023-10-18](https://www.globalkeysolutions.net/records/483/indoco-remedies-limited-plant-i/827c9dfa-eba4-4c24-9439-1db2a1113374)

## Related Officers

- [Research Specialist II](https://www.globalkeysolutions.net/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [Compliance Officer](https://www.globalkeysolutions.net/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)

Company: https://www.globalkeysolutions.net/companies/indoco-remedies-limited-plant-i/cdf789a3-1db2-4bf5-92b5-d6771ea5df48

Office: https://www.globalkeysolutions.net/offices/office-of-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe