# FDA 483 - Haw Par Healthcare Limited - August 19, 2022

Source: https://www.keypedia.com/records/483/haw-par-healthcare-limited/19fa39fa-eb0b-4a0d-9906-a57810ecacf5

> FDA 483 for Haw Par Healthcare Limited on August 19, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Haw Par Healthcare Limited
- Inspection Date: 2022-08-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Haw Par Healthcare Limited, an OTC drug manufacturer in Singapore, revealed significant deficiencies across its quality, production, facilities, and laboratory control systems. The firm failed to adequately investigate out-of-specification results, lacked proper process and cleaning validations, and did not follow or contemporaneously document production procedures. Several observations, including issues with production documentation and hold times, were repeat findings from a previous inspection, indicating persistent non-compliance.

## Related Documents

- [483 - 2019-03-01](https://www.keypedia.com/records/483/haw-par-healthcare-limited/3258265a-6763-438b-a9d4-ac8272b13205)
- [WARNING_LETTER - 2019-03-01](https://www.keypedia.com/records/warning_letter/haw-par-healthcare-limited/094105c2-2599-4ab6-85e7-914f80d45d3c)
- [483 - 2024-09-27](https://www.keypedia.com/records/483/haw-par-healthcare-limited/4dac1d33-1f68-478e-8029-a1ef095208cc)

## Related Officers

- [Jennifer L. Huntington](https://www.keypedia.com/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.keypedia.com/companies/haw-par-healthcare-limited/4624588e-3f62-4c4c-8ea2-297ba6465337

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1