# FDA 483 - Haemonetics Manufacturing, Inc. - September 25, 2019

Source: https://www.globalkeysolutions.net/records/483/haemonetics-manufacturing-inc/6de944ea-ee6e-4ef9-bc53-3939937b3de9

> FDA 483 for Haemonetics Manufacturing, Inc. on September 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Haemonetics Manufacturing, Inc.
- Inspection Date: 2019-09-25
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Haemonetics Manufacturing, Inc. in Covina, CA, a drug manufacturer, received a Form 483 with two observations. The inspection revealed significant delays in submitting NDA-Field Alert Reports for drug products failing specifications. Additionally, the firm's quality control unit procedures, specifically the Field Alert Procedure, were found to be outdated and not adequately in writing.

## Related Officers

- [Elizabeth A. Brown](https://www.globalkeysolutions.net/people/elizabeth-a-brown/a635ca4b-f458-44c5-aa77-e154256d3f34)
- [Senior Consumer Safety Officer ](https://www.globalkeysolutions.net/people/marcus-f-yambot/a2266014-ae7e-4d64-aeba-a8cfb873f100)

Company: https://www.globalkeysolutions.net/companies/haemonetics-manufacturing-inc/aab9e41e-6d0c-40ff-8b54-1621ad7aca1c

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6