# FDA 483 - Haw Par Healthcare Limited - September 27, 2024

Source: https://www.keypedia.com/records/483/haw-par-healthcare-limited/4dac1d33-1f68-478e-8029-a1ef095208cc

> FDA 483 for Haw Par Healthcare Limited on September 27, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Haw Par Healthcare Limited
- Inspection Date: 2024-09-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Haw Par Healthcare Limited, an OTC Drug Manufacturer in Singapore, revealed seven significant observations related to quality control and manufacturing practices. The firm failed to thoroughly investigate out-of-specification results for product impurities, lacked an adequate microbiology testing program, and exhibited poor traceability for drug product lots. Additionally, deficiencies were noted in establishing bulk hold times, managing complaint records, conducting supplier audits, and accurately identifying raw material statuses in their SAP system, indicating a need for improved quality systems.

## 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 - 2022-08-19](https://www.keypedia.com/records/483/haw-par-healthcare-limited/19fa39fa-eb0b-4a0d-9906-a57810ecacf5)

## Related Officers

- [Samantha E. Cleek](https://www.keypedia.com/people/samantha-e-cleek/7305f28f-9c92-427d-86ec-42c0bb6bf3ce)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

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

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