# FDA 483 - PIOUS LABORATORIES PRIVATE LIMITED - February 05, 2025

Source: https://www.keypedia.com/records/483/pious-laboratories-private-limited/6a84e5d8-b597-4277-8195-ef71e7a692e9

> FDA 483 for PIOUS LABORATORIES PRIVATE LIMITED on February 05, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PIOUS LABORATORIES PRIVATE LIMITED
- Inspection Date: 2025-02-05
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Pious Laboratories Private Limited in Rangwasa, India, was cited for deficiencies in its quality control unit and laboratory controls during an FDA inspection. The firm's Quality Unit failed to identify a significant calculation error during raw material analysis, and the company lacks validated formulas and written procedures for critical analytical calculations for its OTC drug products. These issues indicate a lack of robust quality oversight and control over manufacturing processes.

## Related Officers

- [Pharmaceutical Investigator](https://www.keypedia.com/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)

Company: https://www.keypedia.com/companies/pious-laboratories-private-limited/035eea27-c97d-4328-a4b9-38e980607c47

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8