# FDA 483 - Inga Pharmaceuticals - June 12, 2017

Source: https://www.globalkeysolutions.net/records/483/inga-pharmaceuticals/8edaf72b-a2fb-4f60-b740-e8255572b063

> FDA 483 for Inga Pharmaceuticals on June 12, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Inga Pharmaceuticals
- Inspection Date: 2017-06-12
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Inga Pharmaceutical, a manufacturer in Tambaram, Chennai, India, was cited for significant deficiencies during an FDA inspection. Observations included inadequate instrument calibration, lack of label control procedures, and widespread failures within the quality unit regarding procedure adherence, scientific justification, and instruction specificity. The firm also lacked a defined sanitization frequency and failed to validate an Excel worksheet used for critical calculations.

## Related Officers

- [Retired](https://www.globalkeysolutions.net/people/ariel-cruz-figueroa/c6ade050-dbe1-4aa3-b88f-980db51b88b0)

Company: https://www.globalkeysolutions.net/companies/inga-pharmaceuticals/26709dfe-6819-4571-9361-b48f9e814a1d

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd